BEUDAMED
    FDA Adverse Event Other Summary report: N

    SORIN CENTRIFUGAL PUMP 5 (CP5)

    MDR report key: 3780794 · Received April 17, 2014

    Report

    Report Number
    1718850-2014-00108
    Event Type
    Other
    Date Received
    April 17, 2014
    Date of Event
    September 30, 2013
    Report Date
    March 21, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    K112225
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE STOCKERT S5 SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT DURING PRE-OPERATION SET-UP, THE SYSTEM PUMP HEAD WAS ROTATING ERRATICALLY AND DID NOT MAINTAIN ROTATIONS. THE MACHINE WAS NOT USED FOR THE CASE. THERE WAS NO PT INVOLVEMENT. A SORIN GROUP FIELD SERVICE REP WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. WHILE AT THE FACILITY, THE SERVICE REP CHECKED ALL CONNECTIONS AS WELL AS THE OPERATION OF THE EQUIPMENT AND EVERYTHING WAS FOUND TO BE FUNCTIONING PROPERLY. IT WAS ALSO REPORTED THAT THE SORIN EQUIPMENT WAS BEING USED WITH AN ADAPTER AND DISPOSABLE FROM ANOTHER MANUFACTURER. NO MODIFICATIONS WERE TESTED AND APPROVED BY SORIN GROUP (B)(4) FOR THIS FACILITY FOR THE USE OF THE OTHER MFR'S ADAPTER AND DISPOSABLE WITH THE CP5. SORIN GROUP HAS REQUESTED THAT THE SORIN EQUIPMENT BE RETURNED FOR EVAL. TO DATE NO PRODUCT HAS BEEN RETURNED. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING PRE-OPERATION SET-UP, THE SYSTEM PUMP HEAD WAS ROTATING ERRATICALLY AND DID NOT MAINTAIN ROTATIONS. THE MACHINE WAS NOT USED FOR THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236765 SORIN CENTRIFUGAL PUMP 5 (CP5) CARDIOPULMONARY BYPASS PUMP SPEED CONTROL DWA SORIN GROUP DEUTSCHLAND 60-00-60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA