483 Roundup: Devicemakers Cited for MDRs, CAPAs, Complaints, DHRs

December 1, 2017

The FDA flagged four firms for a range of violations including a failure to submit medical device reports to the agency for fatal adverse events.

SynCardia Systems: Tucson, Az.-based SynCardia Systems drew an FDA Form 483 for failing to submit MDRs on adverse event reports for about 70 deaths linked to the use of its device intended to help patients recover after undergoing surgery for artificial heart implants.

A four-day August inspection at the device manufacturing facility revealed it had received information between April 2014 and March 2017 about the deaths of patients who used its Companion 2 Driver System, but it did not submit any MDRs to the agency.

The firm was also cited for having inadequate procedures for device design changes. An FDA investigator reviewed the design history files for its Companion 2 Driver and its Freedom Driver System, and observed that pre and post PMA design changes were “neither included nor referenced in the documents.”

Cadwell Industries: The FDA observed nonconformities related to CAPAs, complaint handling and design validation at Cadwell Industries’ manufacturing facility in Kennewick, Wa.

The facility had no documented plan for verifying the effectiveness, as required by the firm’s CAPA procedure, of at least two CAPAs that had already been marked as effective, according to the Form 483 issued after an August inspection.

The agency’s investigator also found three complaints regarding devices that were returned to Cadwell more than a year ago that had not been evaluated. In addition, the firm had failed to follow its validation procedure for the IOMAX device as production equivalent devices were not used for testing.

BZ Medical: Written MDR procedures had yet to be developed at BZ Medical when the FDA conducted an August inspection at the medical device specifications developer’s facility in Portland, Or.

The firm’s complaint procedure was found to be inadequate in that it lacked provisions for conducting a standardized review of complaints to determine whether an MDR was required and for timely MDR submissions to the FDA, as well as documentation and recordkeeping requirements, the agency’s investigator observed in a Form 483.

Other identified nonconformities relate to the firm’s product purchasing procedures — deemed inadequate as its subcontractors had not been evaluated since 2015 or at all — internal quality audits not being conducted since 2012, and its procedures for device history records, which did not include a requirement for documenting labeling.

CME America: Out of 11 device history records at CME America’s facility in Golden, Co., seven lacked documentation that should have identified existing nonconformities, an FDA inspection revealed.

The agency issued a Form 483 following the inspection conducted from mid-July to early August noting the firm’s procedures for controlling the nonconforming products were inadequate.

CME America had also failed to include revisions made to its manufacturing operations in its device master record for the BodyGuard 323 Infusion Pump, and to provide documentation as evidence that validation activities had been conducted on its molding machines.

In a repeat observation, the agency cited the firm’s procedure for evaluating potential suppliers.

Read the SynCardia Systems Form 483 here: www.fdanews.com/11-30-17-syncardiasystemsllc483.pdf.

Read the Cadwell Industries Form 483 here: www.fdanews.com/11-30-17-cadwellindustriesinc483.pdf.

Read the BZ Medical Form 483 here: www.fdanews.com/11-30-17-bzmedicalinc483.pdf.

Read the CME America Form 483 here: www.fdanews.com/11-30-17-cmeamericallc483.pdf.