BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCELERATOR APS CENTRIFUGE MODULE

    MDR report key: 6158485 · Received December 9, 2016

    Report

    Report Number
    1628664-2016-00300
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    November 18, 2016
    Report Date
    December 21, 2016
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEFICIENCY WAS IDENTIFIED DUE TO AN INCREASE IN COMPLAINTS FOR FAILURES OF THE R100 COMPONENT OF THE MAIN ELECTRONICS BOARD (PARTS 8-35003665-01 AND 8-206623-01). THE SUPPLIER, (B)(4), DETERMINED THAT THE ISSUE IS FROM THE R100 COMPONENT OF THE HETTICH CENTRIFUGE BOARD WHICH WAS TOO SMALL TO WITHSTAND A CURRENT SPIKE. HETTICH RELEASED AN ENHANCED MAIN BOARD REVISION 06 WITH A DIFFERENT R100 RESISTOR. IT IS CONSIDERED ACCEPTABLE TO CONTINUE USING THE AUTOMATION SYSTEM BECAUSE THE ISSUE DOES NOT IMPACT OPERATOR NOR PATIENT SAFETY. THE ACCELERATOR APS OPERATIONS MANUAL AND THE CENTRIFUGE OPERATIONS MANUAL WERE REVIEWED AND SHOW THAT TROUBLESHOOTING AND SAFETY INFORMATION IS PROVIDED. THERE HAVE BEEN NO REPORTED INJURIES FOR THIS ISSUE. IF THE ELECTRICAL COMPONENTS OF THE MAIN ELECTRONICS BOARD FAIL, IT WILL SHUT DOWN THE CENTRIFUGE MODULE. IF THE CENTRIFUGE SHUTS DOWN, THE OPERATOR WILL RECEIVE AN ERROR MESSAGE. THE FREQUENCY OF THIS HAZARD WAS ASSESSED AND IT WAS DETERMINED THAT THOUGH THERE WAS A TREND IN COMPLAINTS, THE OVERALL FREQUENCY OF LOW HAD NOT CHANGED FROM THE PREDICTED FREQUENCY AS OUTLINED IN THE RISK MANAGEMENT FILE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE INSTRUMENT WAS DOWN DUE TO NO POWER IN THE LAB. UPON ABBOTT TSS SITE VISIT, THE R100 COMPONENT OF THE MAIN BOARD SHOWED BURN MARKS. THERE WAS NO FIRE OR SMOKE SEEN, AND NO BURNING SMELL ASSOCIATED WITH THE ISSUE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT, USER SAFETY, OR FACILITY DAMAGE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810411 ACCELERATOR APS CENTRIFUGE MODULE CENTRIFUGE MODULE FOR AUTOMATED SAMPLE HANDLING AND PROCESSING SYSTEM JQP ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 BOARD, MAIN ELECTRONIC| PART NUMBER 8-206623-01