BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCONCENTRATOR BC 60 PLUS, BC 140 PLUS

    MDR report key: 7859975 · Received September 10, 2018

    Report

    Report Number
    8010762-2018-00254
    Event Type
    Malfunction
    Date Received
    September 10, 2018
    Date of Event
    August 13, 2018
    Report Date
    December 13, 2018
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    KDI
    PMA / PMN Number
    K123288
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. (B)(4).

    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- (B)(4). CONTACT PERSON- (B)(6). THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION IN THE LABORATORY OF MANUFACTURER. THE INVESTIGATION WAS PERFORMED BASED ON RECEIVED COMPLAINT PICTURE. IT SHOWS THAT BLOOD LEAK OCCURRED AT TUBING AND DIAMETER CONNECTOR. SAP TREND SEARCH WAS PERFORMED (MATERIAL 70103.5742, FAILURE CODE 0109 CONNECTOR BC) WHICH CAME TO FOLLOWING RESULTS: 0 ADDITIONAL COMPLAINT WAS RECORDED IN THE LAST 12 MONTHS. BASED ON THE SALES FIGURES OF THE LAST 12 MONTHS FOLLOWING OCCURRENCE RATE HAS BEEN CALCULATED:0,2%, WHICH IS BELOW 1%.DUE TO THIS INFORMATION NO SYSTEMIC ISSUE COULD BE DETERMINED. MAQUET CARDIOPULMONARY GMBH IS AWARE OF 1 COMPLAINT FROM THE SAME BATCH, (B)(4). . GETINGE CP ANTALYA WAS INVESTIGATED THE PRODUCTION STEPS OF THE SET, ASSEMBLY OF THE COMPONENTS. IT IS CONCLUDED THAT THE FAILURE COULD BE RELATED WITH OPERATOR MISTAKE. BASED ON THIS FAILURE COULD BE CONFIRMED.

    Description of Event or Problem · 0

    ACCORDING TO THE HOSPITAL: BLOOD LEAK DETECTED AT TUBING AND DIA CONNECTOR. (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703848 HEMOCONCENTRATOR BC 60 PLUS, BC 140 PLUS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI MAQUET CARDIOPULMONARY AG BEQ-H 46971 92222181

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention