BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V. MUELLER OCHSNER ARTERY FORCEPS

    MDR report key: 17457766 · Received August 4, 2023

    Report

    Report Number
    17457766
    Event Type
    Injury
    Date Received
    August 4, 2023
    Date of Event
    July 28, 2023
    Report Date
    August 1, 2023
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    GEN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS BORN VIA CESARIAN SECTION (C/S). UPON ARRIVAL TO THE INFANT WARMER, IT WAS NOTED THE KOCHER CLAMP HAD COME UNDONE RESULTING IN SIGNIFICANT BLOOD LOSS. APGAR SCORE WAS 1 AT 1 MIN AND 5 AT 5 MIN. BABY WAS ADMITTED TO SPECIAL CARE NURSERY FOR RESPIRATORY DISTRESS, STATUS POST RESUSCITATION, AND BLOOD LOSS FROM UMBILICAL CORD. 1.5 HOURS LATER, NURSING NOTED DESATURATIONS AND LOW BLOOD PRESSURE (BP) REQUIRING TRANSITION BACK TO CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) AND A NORMAL SALINE (NS) BOLUS. PEDIATRICIAN CONTACTED NEONATOLOGY WITH A DECISION TO TRANSFER FOR HIGHER LEVEL OF CARE. IN THE NEONATAL INTENSIVE CARE UNIT (NICU) BABY RECEIVED BLOOD PRODUCTS. UNKNOWN AT THIS TIME IF THIS WAS FAILURE OF THE USER TO PROPERLY CLAMP OR IF THE CLAMP ITSELF DID NOT FUNCTION AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951285 V. MUELLER OCHSNER ARTERY FORCEPS FORCEPS, GENERAL & PLASTIC SURGERY GEN CAREFUSION 2200, INC. SU2800 D23XMR

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Female Life Threatening| H| R