BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATORS

    MDR report key: 8850353 · Received August 1, 2019

    Report

    Report Number
    8010762-2019-00231
    Event Type
    Malfunction
    Date Received
    August 1, 2019
    Date of Event
    July 4, 2019
    Report Date
    September 13, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET CARDIOPULMONARY GMBH WAS NOT REQUESTED THE PRODUCT BACK FOR INVESTIGATION SINCE THE ISSUE IS KNOWN. MAQUET CARDIOPULMONARY AG IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT. SIMILAR PRODUCT, SHOWING A SIMILAR MALFUNCTION, HAS BEEN INVESTIGATED IN (B)(4) . UNDER SCOPE OF THE COMPLAINT (B)(4) ; MAQUET CARDIOPULMONARY GMBH WAS RECEIVED THE PRODUCT BACK FOR INVESTIGATION. A QUADROX-I WAS RETURNED. THE PRODUCT WAS CONTAMINATED. VISUAL INSPECTION WAS PERFORMED. A LONG CRACK ON THE LUER LOCK NEAR THE VENT COCK WAS DETECTED, SO, IT WAS DECIDED THAT THE LEAK TEST WAS NOT NECESSARY. NO OTHER ABNORMALITIES COULD BE DETECTED. THE FAILURE WAS CONFIRMED BY THE LABORATORY. THE MANUFACTURER`S REVIEW OF THE CONTROL FORM IN PRODUCTION INDICATED THAT A 100% VISUAL INSPECTION IS CONDUCTED DURING MANUFACTURING. THE INFORMATION OBTAINED SO FAR IN THIS INVESTIGATION WOULD CONFIRM THAT THE DEVICE MET ITS SPECIFICATION AT THE TIME OF MANUFACTURING AND THEREFORE ALL DAMAGES FOUND ON THE PRODUCT ARE DUE TO EXCESSIVE OR INADEQUATE EXTERNAL PHYSICAL FORCE THAT WAS EXERTED ON THE PRODUCT AFTER THE RELEASE.

    Description of Event or Problem · 0

    COMPLAINT: #(B)(4).

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. IMPORTER- (B)(4).

    Description of Event or Problem · 1

    BLEED COCK AT THE INLET OF THE INTEGRATED FILTER DRIPS. COMPLAINT NO: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646805 OXYGENATORS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH QUADROX-I ADULT (VKMO) W/ FILTER

    Patients

    Seq Age Sex Outcome Treatment
    1