BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

    MDR report key: 8148026 · Received December 10, 2018

    Report

    Report Number
    8010762-2018-00322
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Date of Event
    November 8, 2018
    Report Date
    April 26, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWF
    PMA / PMN Number
    K102532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET MEDICAL SYSTEMS,USA(IMPORTER)SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). RASTATT, GERMANY. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. IMPORTER- MAQUET MEDICAL SYSTEMS USA (B)(4). CONTACT PERSON- (B)(6). MAQUET GMBH HAS REQUESTED THE PRODUCT FOR MANUFACTURER INVESTIGATION. HOWEVER,WE WERE INFORMED THAT THE PRODUCT WAS NOT AVAILABLE. BASED ON THE RECEIVED COMPLAINT PICTURE, IT IS CLEARLY SEEN THAT THE SAMPLE WAS CRACKED. ALSO, MAQUET GMBH IS AWARE OF SIMILAR COMPLAINT WHICH WAS REGISTERED AS #(B)(4) .ACCORDING TO LABORATORY INVESTIGATION RESULTS OF (B)(4) ; CLAIMED PART WAS INVESTIGATED. THERE WAS NO SCREW CAP OF THE LUER LOCK ON THE CONNECTOR. SEVERAL CRACKS ON THE LUER LOCK OF THE 3/8X3/8 CONNECTOR WERE DETECTED. LEAK TEST COULD NOT BE CARRIED OUT BECAUSE IT LED TO LEAKAGE THROUGH THE CRACKS. NO FURTHER ABNORMALITIES COULD BE DETECTED. THE FAILURE WAS CONFIRMED BY THE LABORATORY. GETINGE CP ANTALYA HAS BEEN EVALUATED THE PRODUCTION STEPS OF THE SET. THE MOST PROBABLE CAUSE OF THE FAILURE IS FOUND AS MOUNTING FAILURE CAUSED BY OPERATOR. BASED ON THIS FAILURE COULD BE CONFIRMED. SAP TREND SEARCH WAS PERFORMED (MATERIAL 70104.7285, FAILURE CODE CRACK FRACTURE) WHICH CAME TO FOLLOWING RESULTS: 0 ADDITIONAL COMPLAINT WAS RECORDED WHICH APPEARS REPORTED ISSUES ARE THE SAME SINCE THE LAST 12 MONTHS. SAP TREND SEARCH WAS ALSO PERFORMED BASED ON SIMILAR FAILURE CODE AND SAME PRODUCT GROUP.ADDITIONALLY 2 SIMILAR COMPLAINTS WERE FOUND. BASED ON THE SALES FIGURES OF THE LAST 12 MONTHS FOLLOWING OCCURRENCE RATE HAS BEEN CALCULATED: 0,04%, WHICH IS BELOW 1%. DUE TO THIS INFORMATION NO SYSTEMIC ISSUE COULD BE DETERMINED. AS A CORRECTIVE ACTION THE OPERATORS WERE ALREADY TRAINED ABOUT THE SAME FAILURE WHICH WAS REGISTERED AS(B)(4).THE DATA IS BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS.DUE TO THIS NO FURTHER INVESTIGATIONS WILL BE COMPLETED AS THIS TIME.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION YET. MAQUET CARDIOPULMONARY (B)(4) WILL SUBMIT A SUPPLEMENTAL MEDWATCH ON RECEIPT OF FURTHER INFORMATION. (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). REFERENCE EXEMPTION # E2018002.

    Description of Event or Problem · 0

    REF.: #(B)(4), CUST. REF.:(B)(4).

    Description of Event or Problem · 0

    ACCORDING TO THE HOSPITAL: BLOOD LEAKING DURING ECMO THERAPY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987359 CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY AG BE-PAL 1523#BE-HLS 92228965

    Patients

    Seq Age Sex Outcome Treatment
    1