FDA To Device Maker: Complaints Not Properly Investigated

By ThinkReliability Staff

The Food and Drug Administration (FDA) issued a warning letter – a possible precursor to regulatory action – to a manufacturer of pulse oximeters challenging its response to violations identified during a facility inspection in 2013.  Specifically it found that:

1) Complaints of device failures were not adequately investigated,

2) Investigation records did not include required information,

3) Procedures did not identify all potentially affected product, and

4) Causes of failures were not investigated.

The company’s response to the initial violations found during the FDA inspection was found to be unacceptable.  Some of the comments to the FDA regarding the violations were: “The reported event poses no risk to user or patient safety, therefore, no Corrective and Preventive Action required”, “The cable and sensor that were returned with the instrument were also investigated and no problem was found”, “Through the investigation process, it was determined that Masimo’s product did not malfunction”. To each of the violations, the company claimed that either no problem was found, or that the problem did not involve any failures of the pulse oximeters identified in the complaints.

This doesn’t ring true to Diana Zuckerman, the president of the National Center for Health Research.  She says, “It may well be that it’s a user error. But you have to investigate that and show that it’s a user error and not a device error… When a company refuses to respond in any way to the FDA other than to say that the FDA is wrong on every issue, that’s not very credible.  Especially when users made complaints that the company’s product put patients at risk.”

Included in the complaints are that the manufacturer’s pulse oximeters failed to alarm in a patient that died and that they resulted in burns on both an 11-month old and 33-year-old and a skin tear on another patient.  Complaints also indicated issues with consistency of readings and exposed wires at the connection points.  The failures are getting attention not only because FDA warning letters are fairly rare – this is the first such letter to the company in its 25-year history – but also because of the company head’s views on medical errors and funding of the nonprofit Patient Safety Movement Foundation.

Pulse oximeters are used to monitor a patient’s pulse and blood oxygen.  Abnormal readings can indicate a change in a patient’s condition which may require medical intervention.  If the device fails to function, it can lead to patient injury or even death.  Because the devices are intended for use in diagnosis, they are regulated by the FDA and have to conform with FDA practices.  If the violations identified by the FDA in the warning letter are not corrected, the company may face regulatory action.

For now, the company has not released its plans to ensure compliance with the FDA requirements.  The FDA is clearly looking at updates to the investigation process used to respond to customer complaints and ensuring that causes identified as part of those reviews result in changes to other processes, such as manufacturing and quality control.

To view an outline and analysis (in the form of a Cause Map, a visual form of root cause analysis) of the FDA’s findings, click on “Download PDF” above.