BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLS SET ADVANCED 7.0

    MDR report key: 10763564 · Received October 30, 2020

    Report

    Report Number
    8010762-2020-00364
    Event Type
    Malfunction
    Date Received
    October 30, 2020
    Date of Event
    October 2, 2020
    Report Date
    December 23, 2020
    Product Code
    DTZ
    PMA / PMN Number
    K112360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    3 ATTEMPTS WERE PERFORMED BY THE SSU USA (2020-10-01 BY PHONE, 2020-10-05 BY PHONE, 2020-10-12 BY VISIT) TO OBTAIN THE PRODUCT BACK FOR MANUFACTURERS LABORATORY INVESTIGATION. THE ATTEMPTS WERE UNSUCCESSFUL. THEREFORE A LABORATORY INVESTIGATION COULD NOT BE PERFORMED. BY THE PROVIDED PICTURE COULD BE DETERMINED THAT THE TYVEK COVER OF THE HLS TRAY WAS MOST PROBABLE COMPROMISED BY A CUT. THE CUT COULD HAVE BEEN OCCURRED WHEN THE OUTER BOX OF THE HLS SET PACKAGING WAS OPENED WITH AN CUTTER. BY THE PERFORMED DEVICE HISTORY RECORD REVIEW OF OUR R&D PACKAGING ENGINEER IT WAS CONFIRMED THAT THE CUT PROTECTION INSERT WAS INCLUDED INTO THE HLS OUTER BOX.. BESIDE OF THIS A SYMBOL IS PRINTED ON THE OUTER BOX CARTONS OF THE HLS SETS, THAT SHOWS THAT NO BLADE KNIFES SHOULD BE USED TO OPEN THE BOX.. THUS THE REPORTED FAILURE COULD BE CONFIRMED BUT WAS MOST PROBABLE NOT CAUSED BY A PACKAGING MALFUNCTION. THE MOST PROBABLE CAUSE OF THE REPORTED FAILURE COULD BE THAT A BLADE KNIFE WAS USED WITH HEAVY PRESSURE TO OPEN THE CARTON BOX, WHICH ALSO COMPROMISED THE CUT PROTECTION INSERT AND THE STERILE LAYER OF THE TYVEK COVER. WHEN THE EVENT OCCURRED, THE PRODUCT WAS NOT USED FOR PATIENT TREATMENT. THE PRODUCT WAS DIRECTLY INVOLVED IN THE EVENT. THE OCCURRENCE RATE REGARDING THE ABOVE COMPLAINT IS BELOW THE ACCEPTANCE RATE. THUS, NO REMEDIAL ACTION REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿ S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.

    Description of Event or Problem · 0

    COMPLAINT ID:(B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PRODUCT ARRIVED WITH THE PEEL PACK PORTION OF THE HLS SET THAT HAD BEEN COMPROMISED (NOT SEALED) DURING SHIPPING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230654 HLS SET ADVANCED 7.0 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0 70137762

    Patients

    Seq Age Sex Outcome Treatment
    1