BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT JMS CENTRIFUGAL PUMP SYSTEM

    MDR report key: 2414904 · Received January 5, 2012

    Report

    Report Number
    1718850-2011-00279
    Event Type
    Other
    Date Received
    January 5, 2012
    Date of Event
    April 14, 2011
    Report Date
    August 26, 2011
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE JMS CENTRIFUGAL PUMP SYSTEM. THIS INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THE JMS CENTRIFUGAL PUMP SYSTEM IS NOT SOLD IN THE USA; HOWEVER, THE COMPONENTS USED IN THE DEVICE ARE CONSISTENT WITH THOSE USED IN THE STOCKERT SCP CENTRIFUGAL PUMP SYSTEM. THE 510(K) FOR THE SCP CENTRIFUGAL PUMP SYSTEM IS K032213. PLEASE NOTE THAT THIS MDR IS BEING FILED LATE DUE TO A RECENT CHANGE IN THE SORIN GROUP (B)(4) MEDWATCH REPORTING CRITERIA AND SUBSEQUENT REVIEW OF PAST COMPLAINTS TO THE NEW CRITERIA. SORIN GROUP (B)(4) REC'D A REPORT OF A PUMP STOP WITH ERROR CODE ON THE JMS PUMP. THE PUMP WAS HAND CRANKED TO COMPLETE THE CASE. THERE WAS NO ADVERSE PT AFFECT DUE TO THIS INCIDENT. THE JMS CENTRIFUGAL PUMP SYSTEM HAS BEEN RETURNED TO SORIN GROUP (B)(4) FOR EVAL. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A F/U REPORT.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) REC'D A REPORT OF A PUMP STOP WITH ERROR CODE ON THE JMS CENTRIFUGAL PUMP. THE PUMP WAS HAND CRANKED TO MAINTAIN BLOOD FLOW. THE CASE WAS COMPLETED W/O ISSUE. THERE WAS NO ADVERSE PT AFFECT DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STOCKERT JMS CENTRIFUGAL PUMP SYSTEM PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE DTQ SORIN GROUP DEUTSCHLAND 60-02-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1