BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT CENTRIFUGAL PUMP CONSOLE

    MDR report key: 3894273 · Received June 19, 2014

    Report

    Report Number
    1718850-2014-00179
    Event Type
    Other
    Date Received
    June 19, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 23, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K020571
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURERS THE CENTRIFUGAL PUMP CONSOLE. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT OF LOW BLOOD FLOW AND PRESSURE DURING A PROCEDURE WHICH RESULTED IN AN ALARM STOPPING THE PUMP. HAND-CRANKING WAS USED TO MAINTAIN BLOOD FLOW UNTIL A REPLACEMENT PUMP HEAD WAS AVAILABLE. THE USER THEN ATTEMPTED TO REPLACE THE PUMP HEAD WHILE THE MOTOR WAS TURNING WHICH RESULTED IN A LOUD NOISE AND ANOTHER ERROR MESSAGE SO THE UNIT WAS POWERED DOWN TO ALLOW INSTALLATION OF THE NEW PUMP HEAD. ONCE THE REPLACEMENT PUMP HEAD WAS INSTALLED, THE ISSUE WAS RESOLVED. THERE WAS NO REPORT OF PATIENT INJURY. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT OF A LOW BLOOD FLOW AND PRESSURE DURING A PROCEDURE WHICH RESULTED IN AN ALARM STOPPING THE PUMP. HAND-CRANKING WAS USED TO MAINTAIN BLOOD FLOW UNTIL A REPLACEMENT PUMP HEAD WAS AVAILABLE. THE USER THEN ATTEMPTED TO REPLACE THE PUMP HEAD WHILE THE MOTOR WAS TURNING WHICH RESULTED IN A LOUD NOISE AND ANOTHER ERROR MESSAGE SO THE UNIT WAS POWERED DOWN TO ALLOW INSTALLATION OF THE NEW PUMP HEAD. ONCE THE REPLACEMENT PUMP HEAD WAS INSTALLED, THE ISSUE WAS RESOLVED. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360836 STOCKERT CENTRIFUGAL PUMP CONSOLE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE DTQ SORIN GROUP DEUTSCHLAND 60-30-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP