BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHOPAT

    MDR report key: 2546724 · Received April 9, 2012

    Report

    Report Number
    2546724
    Event Type
    Other
    Date Received
    April 9, 2012
    Date of Event
    April 9, 2012
    Report Date
    April 9, 2012
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DURING A TOTAL HIP REPLACEMENT SURGERY, THE ORTHOPAT MACHINE WAS BEING SET UP FOR USE AS AN AUTOLOGOUS BLOOD TRANSFUSION COLLECTOR. THE TUBIN SUPPLIED FROM THE MANUFACTURER WAS OPENED AND AN ATTEMPT TO SET IT UP AS INDICATED PER MANUFACTURERS' INSTRUCTIONS FOR USE WAS MADE. THE STOPCOCKS ON THE TUBING WERE DIFFERENT FROM THE STANDARD TUBING USED AND WOULD NOT FIT IN THE MACHINE VALVE-HOLDERS. LUCKILY, THERE WAS MORE TUBING THAT HAD THE CORRECT-FITTING STOPCOCKS (3-WAY) AND THAT WAS USED. VERIFIED THAT MANUFACTURER NUMBER AND REFERENCE NUMBERS WERE IDENTICAL ON BOTH PACKAGING. RETAINED PACKAGING FROM INCORRECT SET.======================MANUFACTURER RESPONSE FOR PERIOPERATIVE AUTOTRANSFUSION SYSTEM, ORTHOPAT (PER SITE REPORTER).======================PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPAT AUTOTRANSFUSION, PERIOPERATIVE CAC HAEMONETICS CORP. 1150H A12043

    Patients

    Seq Age Sex Outcome Treatment
    1 NO OTHER THERAPIES