BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET

    MDR report key: 5772914 · Received July 6, 2016

    Report

    Report Number
    8010762-2016-00426
    Event Type
    Malfunction
    Date Received
    July 6, 2016
    Date of Event
    June 13, 2016
    Report Date
    April 6, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTM
    PMA / PMN Number
    K001787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY (B)(4) WILL NOT BE ABLE TO INVESTIGATE THE PRODUCT AS IT WILL NOT BE AVAILABLE FOR MANUFACTURER'S INVESTIGATION. DUE TO THE INTERNAL CLINICAL ASSESSMENT IT IS POSSIBLE THAT A HIGHER TRAUMATIZATION OF THE BLOOD COULD BE GIVEN WHICH LEADS TO A HIGHER CLOTTING RISK. ANYWAY THESE FACTORS ARE ALWAYS GIVEN WHEN A HEART-LUNG-MACHINE IS USED. THE MANUFACTURER IS AWARE OF A SIMILAR COMPLAINT SHOWING A SIMILAR MALFUNCTION. THIS SIMILAR EVENT OCCURRED AT THE SAME HOSPITAL. THE PRODUCTS OF THIS SIMILAR COMPLAINT HAS BEEN REQUESTED BUT WERE NOT RECEIVED. AS SOON AS THE INVESTIGATION OF THIS SIMILAR COMPLAINT HAS BEEN FINISHED A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED UNDER SECTION IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE BLOOD FILTER WHICH IS REGISTERED UNDER 510(K): K001787.

    Additional Manufacturer Narrative · 1

    THE RECEIVED COMPLAINT HAS BEEN INVESTIGATED BY (B)(4). THEREBY A DEVICE HISTORY RECORD OF THE REPORTED LOT HAS BEEN INVESTIGATED AND NO ABNORMALITY WAS FOUND. ALL THE CONTROLS WERE DONE ACCORDING TO THE PROCESS CONTROL FORM. MOREOVER, NO SCRAP RECORD FOR THE RELATED PALL FILTER WAS FOUND. BASED ON THE RECEIVED PICTURE THE REPORTED FAILURE COULD BE CONFIRMED BY MAQUET (B)(4). THE MOST PROBABLE CAUSE WAS DETERMINED AS A FAILURE CAUSED BY A OPERATOR MISTAKE. AS A CORRECTIVE ACTION A TRAINING HAS BEEN PERFORMED WITH THE EXPLANATION OF THE ASSEMBLY OF THE FILTER. FURTHERMORE THE OPERATORS OF MAQUET TURKEY HAVE BEEN INFORMED ABOUT THE COMPLAINT. AS SOON AS FURTHER INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET CARDIOPULMONARY (B)(4) WILL NOT BE ABLE TO INVESTIGATE THE PRODUCT AS IT WILL NOT BE AVAILABLE FOR MANUFACTURER'S INVESTIGATION FOR THE COMPLAINT #(B)(4), BECAUSE CONTAMINATED SET WAS THROWED AWAY BY HOSPITAL. ON THE OTHER HAND,4 SETS WERE AVAILABLE FOR INVESTIGATION, AND THE PRODUCT WAS RECEIVED FOR EVALUATION UNDER COMPLAINT #(B)(4). BASED ON THIS INVESTIGATION, THE FILTER HAS BEEN INSPECTED VISUALLY AND IT WAS FOUND THAT THE FILTER HAS BEEN INSTALLED INCORRECTLY. ADDITIONALLY, THE RECEIVED COMPLAINT HAS BEEN INVESTIGATED BY MAQUET CARDIOPULMONARY (B)(4). THEREBY A DEVICE HISTORY RECORD OF THE REPORTED LOT HAS BEEN INVESTIGATED AND NO ABNORMALITY WAS FOUND. BASED ON THE RECEIVED PICTURE THE REPORTED FAILURE COULD BE CONFIRMED BY MAQUET (B)(4). THE MOST PROBABLE CAUSE WAS DETERMINED AS A ASSEMBLY FAILURE CAUSED BY AN OPERATOR MISTAKE. AS A CORRECTIVE ACTION A TRAINING HAS BEEN PERFORMED WITH THE EXPLANATION OF THE ASSEMBLY OF THE FILTER. FURTHERMORE THE OPERATORS OF MAQUET (B)(4) HAVE BEEN INFORMED ABOUT THE COMPLAINT. ADDITIONALLY, A REVIEW FOR SIMILAR COMPLAINTS FOR THE SPECIFIC PRODUCT HAS BEEN PERFORMED AND NO SIMILAR INCIDENT WITH A FAILURE CONFIRMED WAS FOUND. THIS DATA WILL BE HANDLED THROUGH A DESIGNATED MAQUET TRENDING PROCESS. IF A TREND OCCURS, IT WILL BE ESCALATED TO QUALITY ASSURANCE MANAGEMENT FOR REVIEW AND DETERMINATION IF FURTHER INVESTIGATION IS NECESSARY. DUE TO THIS NO FURTHER ACTION WILL BE COMPLETED AT THIS TIME.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    DESCRIPTION FROM THE CUSTOMER REPORT: "AFTER PRIMING PROCEDURE AND STARTING CIRCULATION PERFUSIONIST NOTED FILTER PALL AL3 IS CONVERSELY MOUNTED. UNFORTUNATELY BLOOD WAS ALREADY IN. THERE WAS NO CONSEQUENCE FOR PATIENT. CONTAMINATED SET IS NOT AVAILABLE FOR INVESTIGATION." (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426968 HLM TUBING SET FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE DTM MAQUET CARDIOPULMONARY AG H 99100 92165707

    Patients

    Seq Age Sex Outcome Treatment
    1