BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARTERIAL CANNULA FOR SMALL CHILDREN, 6MM

    MDR report key: 10414630 · Received August 17, 2020

    Report

    Report Number
    3004582654-2020-00031
    Event Type
    Death
    Date Received
    August 17, 2020
    Date of Event
    July 31, 2020
    Report Date
    August 17, 2020
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A CORRECTION IS BEING MADE TO THE MODEL NUMBER AND LOT NUMBER BECAUSE THE CLINIC FORWARDED INCORRECT NUMBERS. WE HAVE REVIEWED THE PRODUCTION RECORDS FOR THE EXCOR APEX CANNULA WITH LOT NO. 00079171. THIS CANNULA WAS PRODUCED ACCORDING TO OUR SPECIFICATION. THE AFFECTED CANNULA, LOT NO. 00079171, WAS IN USE FROM 2019-09-23 UNTIL 2020-07-31 (312 DAYS). THE AFFECTED CANNULA IN USE BY THE PATIENT AT THE TIME OF THE INCIDENT WAS NOT BE RETURNED TO THE MANUFACTURER. THE CAUSE OF THE DAMAGE TO THE CANNULA COULD NOT BE ESTABLISHED DUE TO NOT BEING RETURNED FOR ANALYSIS THE INITIAL MDR HAS A MISTAKE IN MODEL NUMBER AND IS BEING CORRECTED. THE CORRECT MODEL NUMBER IS C18A-020 AND THE CORRECT LOT NUMBER IS 00079171 BECAUSE THE CLINIC FORWARDED INCORRECT NUMBERS.

    Additional Manufacturer Narrative · 1

    WE HAVE REVIEWED THE PRODUCTION RECORDS FOR THE EXCOR ARTERIAL CANNULA WITH LOT. NO 00079799. THIS CANNULA WAS PRODUCED ACCORDING TO OUR SPECIFICATION. THE AFFECTED CANNULA, LOT. NO. 00079799, WAS IN USE FROM (B)(6) 2019 UNTIL (B)(6) 2020 (312 DAYS). THE AFFECTED CANNULA IN USE BY THE PATIENT AT THE TIME OF THE INCIDENT HAS NOT BEEN RETURNED TO THE MANUFACTURER. AN UPDATED REPORT WILL BE PROVIDED FOLLOWING A DETAILED INVESTIGATION.

    Description of Event or Problem · 1

    WE WERE INFORMED BY THE CLINIC THAT A EXCOR CANNULA CONNECTED TO THE LEFT PUMP OF A PATIENT IMPLANTED IN THE EXCOR BVAD CONFIGURATION RUPTURED. ACCORDING TO INFORMATION FROM THE CLINIC, THE PATIENT DIED AFTER THE RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881996 ARTERIAL CANNULA FOR SMALL CHILDREN, 6MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH C18A-020 00079799

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Death