Tag Archives: recall

Root Cause Analysis

Millions of sippy cups recalled

By Kim Smiley

On May 27, 2016, it was announced that 3.1 million Tommee Tippee Sippee spill-proof cups were being recalled because of concerns about mold. The issue came to light after consumers called the company to complain about finding mold in children’s cups and several alarming photos of moldy cup valves were posted on the company’s Facebook page, some shared thousands of times. There have been more than three thousand consumer reports about mold forming in the cup valves, including 68 cases of illness that are consistent with consuming mold.

A Cause Map, a visual root cause analysis, can be built to better understand this issue. The first step in the Cause Mapping process is to fill in an Outline with the basic background information, including how the issue impacts the overall goals. In this case, the safety goal is impacted because 68 cases of illness have been reported. The regulatory call is impacted by the recall of the cups and the economic goal is impacted because of the high cost associated with recalling and replacing millions of cups. The time required to investigate and address the issue can be considered an impact to the labor/time goal. Additionally, the customer service goal is impacted because more than 3,000 consumers have reported mold in their sippy cups and because of the negative social media.

The next step in the Cause Mapping process is to build the Cause Map itself. The Cause Map is built by asking “why” questions and visually laying out the answers to show the cause-and-effect relationships. Understanding the many causes that contribute to an issue can help a broader range of solutions to be considered rather than focusing on a single “root cause” and focusing on solving only one issue. In this example, the mold is growing in the one-piece valve used in this model of cup. The valves remained moist, likely because they are not allowed to dry between uses, and they were not cleaned frequently enough to prevent mold growth. Many consumers have complained that it is very difficult or even impossible to adequately clean the cup valve which has contributed to the mold issue. In addition to the growth of the mold, one of the reasons children have gotten is sick is because it is hard to see the mold. Caregivers are unaware of the fact that the cups are moldy and continue to use them. (To see how these issue might be captured on a Cause Map, click on “Download PDF” above.)

The final step in the Cause Mapping process is to develop and implement solutions that will reduce the risk of the problem from reoccurring. In this case, all cup designs that use the single one-piece valve are being recalled and the valve replaced with either a trainer straw cup with no valve or a sippy cup with a new design two-piece valve that is easier to clean. The new two-piece valve comes apart in such a way that should also make it much easier to identify a potential mold issue, which should hopefully reduce the likelihood that a child will ingest mold. (If you think you may own one of these cups, you can get more information about how to get a replacement here.)

One of the interesting pieces of this case study is that the company has to work to address the technical issue with the valve design, but it also has to work to rebuild consumer trust. Consumers, especially when buying products for small children, will avoid a company if they don’t believe they take safety concerns seriously. This company has taken a beating online by outraged parents in the months leading up to the recall. In addition to designing a valve that will be less likely to harbor mold, it benefited the company to ensure the new design made it easy for parents to see that the cup valve was mold-free and safe. The company has also worked to spread information about the recall and tried to make it easy for consumers to get their recalled cups replaced. How a recall is handled has a huge impact on how consumers respond to the issue. A recall that isn’t handled well on top of an issue that has already shaken consumer trust can quickly spell disaster for a company. Consumers can be much more forgiving of an issue if a company responds quickly and if any necessary recalls are done as quickly and effectively as possible. It will be interesting to see how this company weathers this storm now that the cups have been recalled and the mold issue addressed.

Root Cause

Gamma Camera Collapse Kills Patient

By ThinkReliability Staff

On June 5, 2013, a nuclear medicine scanner was being used for a diagnostic procedure at a New York Veterans Affairs (VA) medical center when the gamma camera collapsed on a patient, causing his death.  This issue can be examined in a Cause Map, or visual root cause analysis, in order to determine both the impact to the organization’s goals as well as the causes of the incident.

In this case, multiple goals were impacted, the first and foremost of which is the death of a patient.  This is an impact to the patient safety goal.  Had the camera collapsed at a different time, it could have also injured an employee, causing an impact to the employee safety goal as well.  The death of a patient due to a medical device that functions other than designed is a “Never Event“, or an event that should never happen in a medical facility.  The scanner collapse on a patient clearly does not meet the goals for patient services.  The property goal is impacted due to potential damage to the scanner. (None of the publicly released reports specified how much damage, if any, was caused to the scanner and camera.)  The scanners of this type from this manufacturer were recalled shortly after this incident, impacting the operations goal and necessitating inspection and/or maintenance activities provided by the manufacturer, an impact to the labor time goal.

Investigation conducted shortly after this patient’s death determined the collapse was caused by loose bolts.  The machines were quickly subject to a Class 1 recall with the FDA.  Sites with the recalled equipment were told to discontinue use until inspections and, if needed, preventive maintenance could be performed by the manufacturer.  Said the manufacturer’s spokesperson, “If no issue is found with the support mechanism fasteners, the site can resume use of the device. If an issue with the support mechanism fasteners is found on a system, the GEHC Field Engineer will coordinate the replacement of impacted parts, and ensure that the system is operating appropriately and meets all specifications.”

Publicly released information about the incident has not specified who was responsible for the preventive maintenance that may have determined the need for tightening the bolts.  However, inspection and maintenance costs were covered by the manufacturer of the devices.

Sites that are using the affected models should have been notified and should stop use until the recommendations of the recall are met.  Although details of broader solutions were not available, both the manufacturer of the devices and the healthcare facilities using them will surely take a look at the preventive maintenance schedule to decrease the risk of patient injury from this type of event.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more.

Root Cause Analysis

Toddler Dies From Contaminated Wipes

By Kim Smiley

A 2 year old boy died December 1, 2010 following a routine surgery to remove a benign cyst from near his spinal cord and brain.  He appeared to be recovering well when he contracted bacterial meningitis and quickly succumbed to the infection.  Tests revealed the bacteria were a rare strain, Bacillus cerus, which is typically associated with food poisoning and not hospital infections.  How the patient was exposed to the bacteria was initially unknown, but now a potential source has been identified.

On January 5, 2011, The Triad Group, one of the nation’s largest medical product suppliers, announced a massive recall of alcohol wipes, swabs and pads because of contamination from the same rare bacteria, Bacillus cerus.  Products by this manufacturer were used to care for the boy during his hospital stay.  Although, a definitive link between the death of the boy and the recalled pads has yet to be established, there is a lawsuit pending.

Since the time of the recall, other people have come forward with possible cases of infection from Bacillus cerus from using the recalled products.  The FDA has launched an investigation.

Even through the investigation is not completed, this example can be built into a Cause Map based on the information that is available.  A Cause Map is an intuitive, visual method of performing a Root Cause Analysis. Any additional information can be added to the Cause Map as it becomes available and any necessary changes made.

When beginning a Cause Map, the first step is to determine the impact to the organizational goals and document them in an Outline.  In this case, the Safety Goal was impacted because a boy died and there is potential that more people were infected by the same harmful bacteria.  Once the impact to the goals is completed, Causes are added to the map by asking “why” questions. In this case, the boy died from bacterial meningitis because he was exposed to Bacillus cerus.  Next, we would ask “why” he was exposed to the bacteria.

Because the link between the recalled wipes and the death of the patient has not been officially determined, a question mark is included with that information when it’s added.  It’s important that all evidence or lack of evidence is documented on the Cause Map so that it is clear which Causes are agreed upon, known facts and which still need to be proven. Click on the “Download PDF” button above to see a high level Cause Map of this example.

The recall is a short term solution to this problem, but at least all products known to be contaminated should be removed from shelves and hospital storerooms.  It isn’t clear yet what steps are needed at the manufacturer to ensure safety of consumers, but the affected products will not be sold again until they are tested and deemed safe.