BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CBC CONSTAVAC PUMP

    MDR report key: 25928 · Received March 8, 1995

    Report

    Report Number
    25928
    Event Type
    Injury
    Date Received
    March 8, 1995
    Date of Event
    September 1, 1994
    Report Date
    February 28, 1995
    Manufacturer
    STRYKER
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED TO ROOM FROM SURGERY AT 1300 ON 8/30/94. 50CC BLOOD IN DRAIN. AT 1555, NO FURTHER DRAINAGE. CLOT NOTED. CANNISTER AND FILTER CHANGED. PHYSICIAN NOTIFIED. AT 1630, STILL NO DRAINAGE. 1800 STILL NO DRAINAGE. PHYSICIAN NOTIFIED. ON 8/31/94, 0830, NO DRAINAGE - BLOOD CLOT IN FILTER - FILTER CHANGED, NO DRAINAGE. ON 9/1/94, 1000 - PHYSICIAN REMOVED DRAIN. 1015, APPROXIMATELY 500CC BRIGHT RED BLOOD POURED FROM DRAIN SITE. PHYSICIAN NOTIFIED. REDRESSED AND PRESSURE DRESSING APPLIED. BLEEDING CEASED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. 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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBC CONSTAVAC PUMP LKK STRYKER 216-3 (PUMP) 216-2-64(BATTERY

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention