BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT

    MDR report key: 7908 · Received March 7, 1994

    Report

    Report Number
    7908
    Event Type
    Malfunction
    Date Received
    March 7, 1994
    Date of Event
    July 22, 1993
    Report Date
    September 10, 1993
    Manufacturer
    ABBOTT LABS
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ATTACHED PUMP TO BROVIAC AND TURNED PUMP ON BUT DID NOT OPEN CLAMP. PUMP INFUSED MEDICATION UNTIL CATHETER BURST. THE PUMP DID NOT ALARM.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT PROVIDER PUMP ABBOTT LABS NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other