BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETERS & CANNULAE

    MDR report key: 11441564 · Received March 9, 2021

    Report

    Report Number
    8010762-2021-00155
    Event Type
    Malfunction
    Date Received
    March 9, 2021
    Date of Event
    June 2, 2020
    Report Date
    March 8, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    PMA / PMN Number
    K102532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT HAS BEEN REPORTED WITH A DELAY DUE TO OUR RETROSPECTIVE EXAMINATION OF THE RECORD. AT THE TIME 03-29-2020. THE COMPLAINT WAS REVIEWED AND FOUND NOT TO BE REPORTABLE. CURRENT DAY, WE COMPARED THE RECORD WITH EQUIVALENT EVENTS, AND FOUND AN INCONSISTENCY WITH THE REPORTING DECISIONS. WITH THE CURRENT KNOWLEDGE AND THE CURRENT TEAM OF COMPLAINT HANDLERS, WE HAVE COME TO CONCLUDE THE EVENT SHOULD HAVE BEEN REPORTED. AS A REMEDIAL EFFORT, WE WILL REPORT IT WITHIN CAPA # (B)(4). MAQUET CARDIOPULMONARY GMBH DID NOT REQUEST THE PRODUCT BACK FOR INVESTIGATION SINCE THE ISSUE IS KNOWN. SIMILAR PRODUCT, SHOWING A SIMILAR MALFUNCTION, HAS BEEN INVESTIGATED IN #238981: A HOLE IN STERILE BAG ON PAPER SIDE CAN BE CONFIRMED. NO WELDING PROBLEM WAS FOUND. FAILURE COULD BE CONFIRMED. DEVICE HISTORY RECORD FOR LOT 92278267 WAS REVIEWED ON (B)(6). 2020. THERE IS NO EVIDENCE INDICATING A NON CONFORMANCE OR DEVIATIONS OF THE PRODUCT IN QUESTION DURING THE MANUFACTURING AND FINAL RELEASE OF THIS SPECIFIC LOT. THE FAILURE IS ALREADY KNOWN TO THE MANUFACTURER. MAQUET CARDIOPULMONARY GMBH HAS ALREADY INITIATED A CAPA (B)(4), BASED ON SEVERAL COMPLAINTS SHOWING THE SAME SYMPTOMS WITH DIFFERENT MATERIAL NUMBERS THAN THE ONE IN THIS COMPLAINT, IN ORDER TO DETERMINE THE ROOT CAUSE AND INITIATE FURTHER ACTIONS TO DETERMINE CORRECTIVE MEASURES FOR THE FAILURE. THIS COMPLAINED PRODUCT WAS MANUFACTURED BEFORE THE CORRECTIVE ACTIONS ARE IMPLEMENTED IN CAPA. THE MOST PROBABLE ROOT CAUSES WERE IDENTIFIED IN DMS # (B)(4).VERSION 01. ONE OF THE ROOT CAUSES IS, PRIMARY PACKAGING CONSIST OUT OF MEDICAL PAPER POUCH WHICH DO SHOW LESS PROTECTION THAN OTHER MATERIALS LIKE TYVEK. AS A CORRECTIVE ACTION, ENGINEERING CHANGE REQUEST #19091002 HAS BEEN INITIATED TO CHANGE STERILE BAG FROM MEDICAL PAPER TO TYVEK AND STRENGTHEN CARDBOARD BOX. BASED ON THIS FAILURE COULD BE CONFIRMED. 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 · 1

    IT WAS REPORTED THAT A HOLE IN THE STERILE PACKING MAKES THE CANNULA UNUSABLE COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344544 CATHETERS & CANNULAE CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH BE-PAL 2123#BE-HLS CANNULA 21F AL 92278267

    Patients

    Seq Age Sex Outcome Treatment
    1