BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOOD PUMP PU VALVES 15 ML, IN/OUT Ø9 MM

    MDR report key: 19164061 · Received April 23, 2024

    Report

    Report Number
    3004582654-2024-00024
    Event Type
    Injury
    Date Received
    April 23, 2024
    Date of Event
    April 9, 2024
    Report Date
    November 14, 2024
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXCOR BLOOD PUMPS, S/N, (B)(6) (RVAD) WAS IN USE ON THE PATIENT FROM 2024-03-26 UNTIL THE TIME OF THE EVENT FOR 14 DAYS. WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP, S/N (B)(6), THE PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION. THE LEFT EXCOR BLOOD PUMP WILL BE SUBMITTED AS 3004582654-2024-00023. A DETAILED INVESTIGATION REPORT WILL BE PROVIDED AS SOON AS IT IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE FOLLOW-UP REPORT 3004582654-2024-00024 FOLLOW-UP 1 WAS ORIGINALLY SUBMITTED ON 10/07/2024. HOWEVER, THE ACKNOWLEDGEMENT 3 WAS NOT RECEIVED. THEREFORE, THIS REPORT IS BEING RE-SUBMITTED BASED ON AN EMAIL FROM FDA DATED 11/12/2024. THE EXCOR BLOOD PUMP, RVAD S/N(B)(6), AND LVAD S/N (B)(6) (3004582654-2024-00023) AND CANNULAS, CONNECTING SETS USED ON PATIENT WERE RETURNED TO BERLIN HEART GMBH ON 2024-04-09 FOR INVESTIGATION. BERLIN HEART PERFORMED A VARIETY OF EXAMINATIONS INCLUDING VISUAL ANALYSIS, FUNCTIONAL TEST, AND INTERNAL EXAMINATION FOR DEPOSITS. THE BLOOD PUMP RVAD S/N(B)(6) WAS CLEANED AND DISINFECTED TO TEST ITS FUNCTIONALITY. NO ABNORMALITIES WERE FOUND. THE PUMP PERFORMANCE MET OUR SPECIFICATIONS. THE PUMP WAS COMPLETELY FILLING AND EMPTYING, AND THE MEMBRANE MOVEMENT SHOWED NO ABNORMALITIES. HOWEVER, OBSERVED A SLIGHTLY LOWER FLOW VOLUME, DUE TO DEPOSIT. NORMAL OPERATING NOISES COULD BE HEARD DURING THE TEST. FURTHERMORE, BLOOD PATHS WERE CHECKED, AND THEY WERE SMOOTH. FOR FURTHER EVALUATION, THE BLOOD PUMP WAS DISASSEMBLED, AND THE INDIVIDUAL MEMBRANE LAYERS WERE EXAMINED. ALL THREE LAYERS WERE INTACT, AND THE GRAPHITE DISTRIBUTION WAS UNIFORM WITHOUT ANY GAPS. NO DEFECTS OR MALFUNCTIONS WERE FOUND. VISUAL INSPECTION OF RETURNED CANNULAS AND CONNECTING SETS, OBSERVED NO DAMAGES. THE CLINIC STATED THAT THERE WERE NO PROBLEMS WITH THE EXCOR SYSTEM DURING THE ENTIRE THERAPY. THE BLOOD PUMPS MAINTAINED COMPLETE FILL AND EJECTION. BASED ON THE EVALUATION FINDINGS EXCOR SYSTEM FUNCTIONED AS INTENDED. DETAILED FAILURE INVESTIGATION REPORT IS ATTACHED.

    Description of Event or Problem · 0

    THE SITE REPORTED THAT THE PATIENT, WHO WAS ORIGINALLY IMPLANTED WITH BVAD EXCOR BLOOD PUMPS ON 2024-03-26 HAD A STROKE ON 04/09/2024, AND THE LEFT SIDE OF THE BODY WAS LIGHTLY RECOVERING. PATIENT WAS NEITHER INTUBATED NOR SEDATED. ACCORDING TO THE SITE, THE PATIENT PREVIOUSLY HAD VIRAL INFECTION AT THE TIME OF IMPLANTATION AND LATER BACTERIAL INFECTION. FIBRIN CLOTS WERE OBSERVED ON BOTH THE PUMPS. THROMBECTOMY WAS PERFORMED AND FIBRIN WAS REMOVED AFTER THE STROKE EVENT AND DEPOSITS ARE UNDER CONTROL. HOWEVER, SLIGHT DEPOSITS WERE FOUND IN BOTH PUMPS, ESPECIALLY IN THE RIGHT SIDE. THE PUMPS FUNCTIONED AS INTENDED. THE PATIENT WAS WITHDRAWN FROM SUPPORT UPON REQUEST BY THE PATIENT'S FAMILY AND DIED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083087 BLOOD PUMP PU VALVES 15 ML, IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P15P-001 04260090040157

    Patients

    Seq Age Sex Outcome Treatment
    1 21 MO Male Life Threatening