BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERLIN HEART EXCOR DRIVING TUBE, BLUE

    MDR report key: 12781121 · Received November 9, 2021

    Report

    Report Number
    3004582654-2021-00052
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    November 2, 2021
    Report Date
    November 9, 2021
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040560
    PMA / PMN Number
    P160036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXCOR DRIVING TUBE (RED) WITH LOT NUMBER 00094146 WAS USED FROM (B)(6) 2021 TO (B)(6) 2021 (39 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR DRIVING TUBE WITH THE LOT NUMBER 00094146. THIS DRIVING TUBE WAS PRODUCED ACCORDING TO OUR SPECIFICATION. THE CLINIC HAS INFORMED US THAT THE DRIVING TUBE IN QUESTION WAS ALREADY DISPOSED. THEREFORE BERLIN HEART COULD NOT ANALYSE THE PRODUCT IN QUESTION. THE CLINIC DID NOT PROVIDE US WITH FURTHER INFORMATION SUCH AS PICTURES OR VIDEOS OF THE DEFECT. DUE TO THE FACT, THAT THE PRODUCT WAS NOT AVAILABLE FOR ANALYSIS WE CAN NOT DREW ANY CONCLUSION REGARDING THE COMPLAINED DEFECT NOR ITS CAUSE.

    Additional Manufacturer Narrative · 0

    THE EXCOR DRIVING TUBE (RED) WITH LOT NUMBER 00094146 WAS USED FROM (B)(6) 2021 TO (B)(6) 2021 (39 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR DRIVING TUBE WITH THE LOT NUMBER 00094146. THIS DRIVING TUBE WAS PRODUCED ACCORDING TO OUR SPECIFICATION. A DETAILED INVESTIGATION REPORT WILL BE PROVIDED AS SOON AS IT IS AVAILABLE.

    Description of Event or Problem · 0

    BERLIN HEART (B)(4) WAS INFORMED BY THE CLINIC THAT A LEAKAGE WAS DETECTED IN THE DRIVING TUBE OF THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION. THE DRIVING TUBE WAS EXCHANGED IN THE CLINIC. THE EXCHANGE WAS PERFORMED WITHOUT COMPLICATIONS. THE PATIENT WAS NOT NEGATIVELY AFFECTED BY THE EXCHANGE AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1681003 BERLIN HEART EXCOR DRIVING TUBE, BLUE VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH L20H-002X02 00094146 04260090040560

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male