BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA RP

    MDR report key: 6856311 · Received September 11, 2017

    Report

    Report Number
    1220648-2017-00071
    Event Type
    Malfunction
    Date Received
    September 11, 2017
    Date of Event
    August 10, 2017
    Report Date
    September 21, 2017
    Manufacturer
    ABIOMED EUROPE GMBH
    Product Code
    OJE
    UDI-DI
    00813502010022
    PMA / PMN Number
    H14001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE INITIAL MEDWATCH REPORT WAS FILED AND SUBMITTED ON SEPTEMBER 11, 2017 THE PRODUCT AND DATA LOGS WERE RETURNED FOR ANALYSIS. THE IMPELLA RP PUMP WAS INSPECTED AND RUN THROUGH ABIOMED IN-HOUSE HEMOLYSIS TESTING. THE PUMP PASSED HEMOLYSIS TESTING. THE ROOT CAUSE OF THE HEMOLYSIS COULD NOT BE DETERMINED. THE DATA LOGS WERE ANALYZED AND THE LOGS SHOW THAT THE PUMP PERFORMED WITHOUT ISSUE. NO CORRECTIVE ACTION IS RECOMMENDED AS THE FAILURE MODE WAS UNABLE TO BE DETERMINED. THE FAILURE MODE WILL BE TRENDED AND MONITORED. INTERNAL REFERENCE (B)(4).

    Additional Manufacturer Narrative · 1

    TO DATE THE IMPELLA RP PUMP PRODUCT AND DATA LOGS HAVE NOT BEEN RETURNED FOR INVESTIGATIVE ANALYSIS. THE RETURN PROCESS FROM THE FIELD HAS BEGUN. PENDING RETURN OF THE PRODUCT AND DATA LOGS, THE ONLY REVIEW POSSIBLE HAS BEEN THAT OF THE MANUFACTURING RECORDS. THERE ARE NO OTHER COMPLAINTS MADE AGAINST THIS LOT OF IMPELLA RP PUMPS FOR THE FAILURE MODE OF HEMOLYSIS. THE ROOT CAUSE OF THE HEMOLYSIS CAN NOT BE DETERMINED AT THIS TIME. THE MANUFACTURER WILL CONTINUE TO INVESTIGATE ALL REASONABLE OBTAINABLE SOURCE INFORMATION, AND WILL FILE A SUPPLEMENTAL MEDWATCH REPORT IF THEY BECOME AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ON THE (B)(6), A (B)(6) YEAR OLD MALE WAS ADMITTED WITH BACK AND SHOULDER PAIN. THE PATIENT WAS TAKEN TO THE CARDIAC CATHETERIZATION LAB AND A VENTRICULAR SEPTAL DEFECT (VSD) WAS OBSERVED. THE VSD WAS THOUGHT TO BE CAUSED BY A MYOCARDIAL INFARCTION. AN IMPELLA CP WAS PLACED FOR SUPPORT. FOUR DAYS LATER, ON THE (B)(6), DUE TO RIGHT VENTRICULAR FAILURE, AND IMPELLA RP WAS PLACED FOR RIGHT HEART SUPPORT. THE PATIENT RETURNED TO THE ICU AND WAS MONITORED FOR RIGHT HEART FILLING AND GIVEN FLUIDS. THE PATIENT'S CONDITION DECOMPENSATED ON THE NIGHT OF THE (B)(6) AND THE TEAM DREW LABS TO CONFIRM A DIAGNOSIS OF HEMOLYSIS. AFTER TWENTY TWO HOURS OF IMPELLA RP SUPPORT THE PUMP, THE RP WAS EXPLANTED AND VA- EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS PLACED DUE TO CONCERNS OF HEMOLYSIS. ON THE (B)(6), THE TEAM CARED FOR THE HEMOLYSIS AND PROCEEDED WITH SUPPORT. THE PATIENT'S SUPPORT CONTINUED WITH THE VA- ECMO AND IMPELLA CP FOR TEN MORE DAYS. DURING THESE DAYS OF SUPPORT, THE PATIENT EXPERIENCED MULTIORGAN FAILURE, WAS PLACED ON DIALYSIS, RECEIVED BLOOD PRODUCT REPLACEMENT, AND EVENTUALLY CARE WAS WITHDRAWN. THE PATIENT EXPIRED ON THE (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636622 IMPELLA RP PUMP, BLOOD,CARDIOPULMONARY BYPASS NON-ROLLER TYPE OJE ABIOMED EUROPE GMBH IMPELLA RP 1289242 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R