BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCELERATOR APS CENTRIFUGE MODULE

    MDR report key: 2024323 · Received March 18, 2011

    Report

    Report Number
    1628664-2011-00121
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Report Date
    March 12, 2011
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, REVIEW OF A HISTORICAL INVESTIGATION FOR THE SAME ISSUE, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE HISTORICAL INVESTIGATION FOUND A DEFICIENCY IN THE DESIGN OF THE THERMISTOR WAS RECOGNIZED, AS A MORE ROBUST THERMISTOR SHOULD BE USED FOR THIS APPLICATION. (B)(4) OTHER LEVEL 2 COMPLAINT WAS FOUND WHICH NOTED THAT THE THERMISTOR HAD MELTED THROUGH OTHER PARTS AND PRESENTED A POTENTIAL ELECTRICAL SHOCK RISK. THE ACCELERATOR APS OPERATIONS MANUAL PROVIDES TROUBLESHOOTING ASSISTANCE FOR ANY SYSTEM ISSUE. THE THERMISTOR MANUFACTURER HAS BEEN ASSIGNED A ROOT CAUSE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. AN INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE CENTRIFUGE MODULE OF THE ACCELERATOR APS WOULD NOT START. ABBOTT FIELD SERVICE FOUND THE THERMISTORS AND TERMINAL BLOCK TO BE MELTED. IN ADDITION, THE INSULATION OF INCOMING WIRES WERE MELTED AND FUSED TOGETHER. ABBOTT FIELD SERVICE REPLACED THE THERMISTORS, TERMINAL BLOCK, AND INCOMING WIRES. THE INCOMING LINE VOLTAGE WAS CHECKED, AND THE CENTRIFUGE OPERATED ACCEPTABLY. AN INITIAL INVESTIGATION FOUND A DEFICIENCY IN THE DESIGN OF THE THERMISTOR. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT OR INJURY TO PERSONNEL REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) THERMISTOR PART (B)(4)| (B)(4) THERMISTOR PART (B)(4)