BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS

    MDR report key: 9271192 · Received November 4, 2019

    Report

    Report Number
    8010762-2019-00346
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Report Date
    December 24, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K132829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT COULD NOT BE RECEIVED FROM THE CUSTOMER. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE SIMILAR COMPLAINT, SHOWING SIMILAR FAILURE. ACCORDING TO THE SAMPLE INVESTIGATION OF THE COMPLAINT (B)(4): ''THE SAMPLE WAS PRIMED. THE SAMPLE WAS RINSED WITH WATER. AND LEAK TEST WAS PERFORMED. A LEAK WAS DETECTED ON THE LUER LOCK OF THE TEMPERATURE PROBE. THE TEMPERATURE SENSOR HAS SMALL CRACKS.'' BASED ON THIS, FAILURE COULD BE CONFIRMED. DEVICE HISTORY RECORD FOR COMPLAINT COULD NOT BE REVIEWED SINCE THE LOT NUMBER OF THE PRODUCT IS UNKNOWN. TREND SEARCH WAS PERFORMED. BASED ON THE SALES FIGURES OF THE LAST 12 MONTHS FOLLOWING OCCURRENCE RATE HAS BEEN CALCULATED: 0,17% WHICH IS BELOW THAN ACCEPTED RATE. DUE TO THIS INFORMATION NO SYSTEMIC ISSUE COULD BE DETERMINED AT THIS MOMENT. THE MANUFACTURER`S REVIEW OF THE QUALITY CONTROL PROCESS INDICATED THAT A 100% FUNCTIONAL INSPECTION FOR LEAKAGE 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. THIS COMPLAINT IS BEING MONITORED AS PART OF THE COMPLAINT DATA TRENDING OF MAQUET CARDIOPULMONARY GMBH AND FURTHER INVESTIGATIONS AND MEASURES WILL BE CONDUCTED IN CASE OF ADVERSE TRENDING.

    Description of Event or Problem · 0

    (B)(4).

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ''DURING MY VISIT TO THE (B)(6). A PERFUSIONIST EXPLAINED TO ME THAT THEY HAD A LEAK AT A CONNECTOR ON A PEDIATRIC BO HQV 34513 PACK. THIS LEAK OCCURRED DURING A PROCEDURE IN SEPTEMBER. THIS LEAK HAD NO IMPACT ON THE PATIENT. WE OPENED A PACKAGE OF THE SAME LOT TO LOCATE THE LOCATION OF THE LEAK AND FOUND THAT THE CONNECTION WAS NOT TIGHT. THEY NO LONGER WANT TO USE THE LAST 3 PACKS WITH THIS LOT NUMBER.'' (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069165 QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH BO HQV 34513

    Patients

    Seq Age Sex Outcome Treatment
    1