BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HQV #3503 PACK ADULT 1/2 - 3/8

    MDR report key: 4580965 · Received March 4, 2015

    Report

    Report Number
    8010762-2015-00225
    Event Type
    Injury
    Date Received
    March 4, 2015
    Date of Event
    February 4, 2015
    Report Date
    February 5, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED FOR RETURN, BUT HAS NOT BEEN RECEIVED. THE INVESTIGATION IS STILL PENDING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFO BECOMES AVAILABLE. ADDITIONAL INFO: THE PRODUCT MENTIONED IS A TUBING SET WITH RESERVOIR AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE RESERVOIR WHICH IS REGISTERED UNDER 510 (K): K101153.

    Description of Event or Problem · 1

    IT WAS REPORTED JUST PRIOR TO INITIATING THE ECC PROCEDURE, AFTER CONNECTING THE ARTERIAL LINE TO THE ARTERIAL CANNULA, A POOL OF SERUM ALBUMIN QUICKLY APPEARED FROM THE DEVICE WHEN THE ARTERIAL LINE WAS CLAMPED. ADDITIONAL INFO RECEIVED: DELAY OF TREATMENT: 20 MINUTES (TIME FOR THE PRIMING OF THE NEW OXYGENATOR), THE LEAK APPEARED BEFORE BLOOD ARRIVED TO THE DEVICE. THE USER REPORTED A MASSIVE LEAK OF SERUM ALBUMIN (NO BLOOD LOSS). THEY CLAMPED BEFORE AND AFTER THE DEVICE AND REPLACED THE DEVICE. NO REPORTED PT EFFECT. ECC- EXTRA CORPOREAL CIRCUIT. REF.: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152494 HQV #3503 PACK ADULT 1/2 - 3/8 PACK ADULT 1/2 - 3/8 DTZ MAQUET CARDIOPULMONARY AG 70102.9025 92142498

    Patients

    Seq Age Sex Outcome Treatment
    1 Other