Applied Medical Warned After Patient Death Reports

May 22, 2015

Inadequate complaint and CAPA procedures following reports of serious incidents including patient deaths led to a warning letter for a California surgical equipment manufacturer.

The April 10 letter followed a Form 483 resulting from a Nov. 3 through Dec. 16, 2014, inspection of Applied Medical Resource’s Santa Margarita, Calif., facility.

According to the investigator from the FDA’s Los Angeles district office, the company failed to adequately evaluate and investigate complaints involving possible failure of a device. Applied Medical didn’t fully document test methods used in its investigations and didn’t provide raw test results or perform trending on multiple, repeat complaint types.

Applied Medical received 94 complaints in 2014 related to buttons on a suction/irrigation device getting stuck in the “on” position. The company also received reports that its Kii Trocar cannula installer malfunctioned. In another customer report involving the company’s Kii Shielded Blade System, the knife didn’t return to the trocar and a patient’s artery was cut, resulting in death a few days later, the warning letter says. In yet another report, a patient died after an artery was cut during introduction of the trocar.

Gary Johnson, group president of Applied Medical’s surgical group, said that the deaths were not caused by failure of device performance. The products used in those cases were returned to Applied Medical and found to meet all applicable specifications and performed as intended.

The two incidents are consistent with the inherent risks of laparoscopic surgery, and user error or abnormal patient anatomy may have contributed, Johnson adds.

The warning letter faults Applied Medical for failing to implement CAPA procedures in response to complaints. Specifically, the company didn’t analyze quality data so that appropriate corrective actions could be identified.

The FDA chides the devicemaker’s design validation procedures, citing a missing “Use by Date” report for the Kii Shielded Blade Access System and missing temperature data for the samples being tested. The investigator asked for the data during the inspection, but it wasn’t provided, the warning letter says.

The company provided temperature logs and said it opened a corrective action request regarding data logging, but the FDA called the response inadequate because it didn’t include the report and lacked acceptance criteria.

Johnson says the company is cooperating with FDA.

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