BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIFURCATED TRANSPAC® IT MONITORING KIT W/03 ML FLUSH DEVICE, ADAPTOR ROTATING MA

    MDR report key: 8510394 · Received April 12, 2019

    Report

    Report Number
    9617594-2019-00114
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Date of Event
    March 22, 2019
    Report Date
    March 22, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    DRS
    UDI-DI
    00840619056421
    PMA / PMN Number
    K052828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED ON 5/7/2019.

    Additional Manufacturer Narrative · 0

    ONE USED PARTIAL SET 011-46106-13 BIFURCATED TRANSPAC IT MONITORING KIT AND ONE NEW AND UNOPENED 011-46106-13 BIFURCATED TRANSPAC IT MONITORING KIT WERE RECEIVED FOR EVALUATION. THE REPORTED COMPLAINT OF INACCURATE READINGS COULD NOT BE CONFIRMED ON THE TWO RETURNED MONITORING KITS. BOTH WERE PRESSURE LEAK TESTED AND NO OCCLUSIONS OR LEAKS WERE OBSERVED. FURTHER, THE TRANSDUCERS WERE ELECTRICALLY TESTED AND WERE FOUND TO MEET PRODUCT SPECIFICATIONS. A DHR LOT# 3704820 AND RELEVANT COMMODITIES WERE REVIEWED AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO RETURN FOR EVALUATION. IT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE DATE OF THE EVENT IS UNKNOWN. THE EVENT INVOLVED A BIFURCATED TRANSPAC® IT MONITORING KIT W/03 ML FLUSH DEVICE, ADAPTOR ROTATING MALE/FEMALE AND MACRODRIP®. IT WAS REPORTED THAT THE PRESSURE HEAD INDICATED ERRONEOUS BLOOD PRESSURE VALUES DURING INDUCTION OF ANESTHESIA, RESULTING IN INADEQUATE ADMINISTRATION OF AN UNSPECIFIED VASOACTIVE DRUG. THE PRESSURE CIRCUIT WAS COMPLETELY REPLACED QUICKLY, WHICH SOLVED THE PROBLEM, BUT WHEN EXTRA-CORPOREAL CIRCULATION WAS RELEASED, THE PROBLEM WAS AGAIN REPRODUCED DURING A CRITICAL MOMENT OF THE INTERVENTION. THE SITUATION THEN NORMALIZED. THERE WERE NO CONSEQUENCES REPORTED. THIS REPORT IS FOR THE SECOND DEVICE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300977 BIFURCATED TRANSPAC® IT MONITORING KIT W/03 ML FLUSH DEVICE, ADAPTOR ROTATING MA TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 3704820 00840619056421

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSP VASOACTIVE DRUG.