BEUDAMED
    FDA Adverse Event Death Summary report: N

    "BIO PUMP PLUS, BPX80, STERILE"

    MDR report key: 5019266 · Received August 20, 2015

    Report

    Report Number
    2184009-2015-00036
    Event Type
    Death
    Date Received
    August 20, 2015
    Date of Event
    July 18, 2015
    Report Date
    July 22, 2015
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DWE
    PMA / PMN Number
    K973011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    MEDTRONIC IS ATTEMPTING TO OBTAIN THE EVENT DEVICE FOR EVALUATION AND MORE DETAILED INFORMATION REGARDING THE EVENT. WHEN NEW INFORMATION IS RECEIVED AND/OR THE DEVICE IS RETURNED AND ANALYZED A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REPORTING THAT DURING USE OF THIS BIO PUMP IN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), ELEVATED TEMPERATURES WERE OBSERVED IN THE AREA NEAR THE PUMP HEAD. THE USER WAS RUNNING THE SYSTEM AT APPROXIMATELY 3000 REVOLUTIONS PER MINUTE WITH APPROXIMATELY 3 L/MIN. OF FLOW WHEN BLOOD CLOTTING OCCURRED WITHIN THE CIRCUIT AND PLASMA LEAKAGE WAS OBSERVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO DETERMINE HOW LONG THE BIO PUMP HAD BEEN IN USE BEFORE THE ELEVATED TEMPERATURES AND CLOTTING WERE OBSERVED. IT WAS FURTHER REPORTED THAT THE PATIENT DIED DURING ECMO SUPPORT, BUT IT WAS NOT SPECIFIED WHETHER THE REPORTED EVENT WAS ASSOCIATED WITH THE PATIENT'S DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED. PRODUCT RETURN HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552507 "BIO PUMP PLUS, BPX80, STERILE" TUBING, PUMP, CARDIOPULMONARY BYPASS DWE PERFUSION SYSTEMS 95201 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death