BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8827659 · Received July 25, 2019

    Report

    Report Number
    3004582654-2019-00067
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Date of Event
    July 5, 2019
    Report Date
    July 25, 2019
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXCOR BLOOD PUMP,S/N (B)(4),WAS IN USE BY THE PATIENT FROM (B)(6) 2019 UNTIL (B)(6) 2019 (44 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP, S/N (B)(4). THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION. THE AFFECTED BLOOD PUMP WAS RETURNED TO BERLIN HEART FOR ANALYSIS FOLLOWING THE EXCHANGE. THE CUSTOMER COMPLAINT COULD BE CONFIRMED. DURING INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP, AN AIR CUSHION WAS DETECTED BETWEEN THE MEMBRANE LAYERS. THE PUMP WAS THEN DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY TESTED. A LEAK WAS DETECTED IN THE AIR-SIDE LAYER, LOCATED ALONG THE ROLLING RADIUS OF THE STABILIZATION RING. FURTHERMORE, A FEW GRAPHITE AGGLOMERATES WERE DETECTED BETWEEN THE MEMBRANE INTERSTICES. THE BLOOD-SIDE AND MIDDLE LAYERS OF THE TRIPLE LAYER MEMBRANE WERE FOUND TO BE INTACT. THE THICKNESS OF THE DEFECTIVE MEMBRANE LAYER AND THE ADJACENT LAYER WAS RE-MEASURED AT FIXED POINTS. AT THE TIME OF INVESTIGATION, THE THICKNESS OF THE LAYERS AT THE FIXED LOCATIONS AND ALSO AT THE REGION OF THE DEFECT WAS FOUND TO BE WITHIN SPECIFICATION. THE CAUSE OF THE DEFECT WAS MOST LIKELY THE GRAPHITE PARTICLES THAT FORMED DUE TO AN ABRASION BETWEEN THE LAYERS. THIS CAUSED INCREASED FRICTION AT POINTS, WHICH FINALLY LED TO THE DEFECT IN THE AIR-SIDE LAYER OF THE TRIPLE-LAYER MEMBRANE. AS A RESULT OF THIS DEFECT, AIR GOT IN AND FORMED AN AIR CUSHION (PILLOW) IN THE MEMBRANE INTERSTICES, CAUSING THE REDUCED PUMP PERFORMANCE (INCOMPLETE FILLING AND EMPTYING).

    Description of Event or Problem · 1

    ON (B)(6) 2019 AROUND 2 AM, INCOMPLETE EJECTION OF THE EXCOR BLOOD PUMP WAS NOTED AND THE PATIENT CONDITION WAS DECLINING, FEBRILE, HEMODYNAMIC INSTABILITY AND TROUBLE BREATHING WITH DECREASED OXYGEN SATURATIONS THAT REQUIRED INTUBATION AND MECHANICAL VENTILATION. A CHEST X-RAY WAS TAKEN AND PULMONARY EDEMA WAS NOTED. ACCORDING TO THE SITE, AN ADJUSTMENT OF THE IKUS DID NOT IMPROVE THE SITUATION. BERLIN HEART WAS NOT NOTIFIED UNTIL LATER THAT DAY AFTER THE EVENT. THE SITE SENT BERLIN HEART INC. A VIDEO. UPON REVIEW OF THE VIDEO, AN AIR PILLOW WAS SEEN AND BERLIN HEART INC. RECOMMENDED AN IMMEDIATE EXCHANGE OF THE AFFECTED BLOOD PUMP. TRAINED PERSONNEL AT THE SITE PERFORMED AN EXCHANGE OF THE AFFECTED PUMP WITHOUT COMPLICATIONS AND THE PATIENT WAS DOING WELL AGAIN AFTER THE EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620355 EXCOR 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 17 MO Other| R