BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION PUMP

    MDR report key: 5321 · Received March 15, 1993

    Report

    Report Number
    5321
    Event Type
    Malfunction
    Date Received
    March 15, 1993
    Date of Event
    February 12, 1993
    Manufacturer
    MCGAW-HORIZON
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ON FEBRUARY 12, 1993 WAS ADVISED OF TWO SEPARATE INSTANCES WHEN TUBING WAS SEVERED COMPLETELY BY THE METAL CLIP THAT PINCHES TUBING WHERE IT EXITS INFUSION PUMP. EVALUATION TO ASCERTAIN THE MECHANICAL CAUSE OF THESE OCCURRENCES WAS UNDERTAKEN ON FEBRUARY 16, 1993. A SERIOUS PATIENT BLEED NECESSITATING BLOOD TRANSFUSION RESULTED FROM ONE OF THESE OCCURRENCESINVALID 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 INFUSION PUMP FRN MCGAW-HORIZON

    Patients

    Seq Age Sex Outcome Treatment
    1 Other