BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VKMO 30000 # QUADROX - I PAD. MIT RESERVOIR

    MDR report key: 4927934 · Received July 17, 2015

    Report

    Report Number
    8010762-2015-00823
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 2, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTM
    PMA / PMN Number
    K102919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED YET FOR EVALUATION. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED IS A TUBING SET WITH RESERVOIR AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE RESERVOIR WHICH IS REGISTERED UNDER 510 (K): K102919. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AFTER RECEIPT OF NEW INFORMATION.

    Additional Manufacturer Narrative · 1

    THE SET WAS NOT AVAILABLE FOR INVESTIGATION. THE CUSTOMER HAD SCRAPPED IT AND REPLACED IT. PHOTOGRAPHS ARE AVAILABLE. AN INVESTIGATION BY MAQUET (B)(4) BASED ON THE AVAILABLE INFORMATION AND THE PHOTOGRAPHS CONCLUDED THAT THE ROOT CAUSE OF THE PROBLEM COULD NOT BE ESTABLISHED AS THERE WAS INSUFFICIENT INFORMATION CONCERNING THIS COMPLAINT. A DHR REVIEW OF LOT 92152104 AND INCOMING INSPECTION REPORTS FOR THE FILTERS FOR THE RESERVOIR IN QUESTION WERE CHECKED AND NO ABNORMALITIES WERE FOUND. ADDITIONAL INFORMATION REGARDING THE CASE WAS REQUESTED THREE TIMES. SOME ANSWERS WERE AVAILABLE ON 2015-12-22 TO THE QUESTIONS SENT OUT, BUT THESE WERE NOT SUFFICIENT TO HELP DETERMINE ROOT CAUSE. TO TRY TO ESTABLISH ROOT CAUSE, A CLINICAL EVALUATION NOTED THAT THE FUNCTION OF UNIT COULD BE IMPAIRED DURING OPERATION IF IT WAS NOT USED AS INTENDED, HOWEVER NO FURTHER INFORMATION RELATED TO ACTUAL USE IS AVAILABLE. A REVIEW FOR SIMILAR COMPLAINTS HAS BEEN PERFORMED AND ONLY ONE SIMILAR INCIDENT FROM THE SAME INSTITUTION WAS FOUND. BASED ON THIS, A CONFIRMATION OF THE FAILURE BASED ON PREVIOUS COMPLAINTS IS NOT POSSIBLE, AND THERE IS NO SYSTEMIC ISSUE INDICATED. 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

    ACCORDING TO THE CUSTOMER: "OXYGENATOR AND CIRCUIT WAS PRIMED WITH CLEAR PRIME INITIALLY AND CIRCULATED THEN CIRCUIT WAS PRIMED WITH BLOOD. RESERVOIR WAS CLOGGED AND WAS NOT FUNCTIONAL. BLOOD WAS INFUSED USING TRANS FUSION SET. TREATMENT WAS DELAYED BY 30 MIN." IT TOOK PLACE DURING PRIMING, NO KNOWN CONSEQUENCES TO THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466833 VKMO 30000 # QUADROX - I PAD. MIT RESERVOIR FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE DTM MAQUET CARDIOPULMONARY AG 70105.0111 92152104

    Patients

    Seq Age Sex Outcome Treatment
    1