BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAEMOCELL SYSTEM 350

    MDR report key: 5327 · Received April 20, 1993

    Report

    Report Number
    1811755-1993-00002
    Event Type
    Malfunction
    Date Received
    April 20, 1993
    Date of Event
    February 2, 1993
    Report Date
    February 23, 1993
    Manufacturer
    HAEMOCELL PLC
    Product Code
    KSW
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE DEVICE CEASED TO FUNCTION DURING USE, DISALLOWING THE REINFUSION OF 500CC OF A PATIENT'S AUTOLOGOUS BLOOD. NO INJURY WAS REPORTED.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT 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. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. 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: INVALID DATA. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAEMOCELL SYSTEM 350 AUTOLOGOUS BLOOD PROCESSING SYSTEM KSW HAEMOCELL PLC 216-350-110 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other