BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

    MDR report key: 4929618 · Received July 16, 2015

    Report

    Report Number
    9611109-2015-00239
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    February 5, 2015
    Report Date
    April 3, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND GMBH
    Product Code
    DWA
    PMA / PMN Number
    K032213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP. THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF (B)(4). A (B)(4) FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE PROVIDED A LOANER UNIT TO THE CUSTOMER AND THE REPLACED UNIT WAS RETURNED TO (B)(4) FOR FURTHER EVALUATION. DURING INVESTIGATION AT (B)(4), THE NOISE ISSUE COULD BE REPRODUCED. UPON FURTHER INSPECTION, SIGNS OF FLUID INGRESS AND DIRT WERE NOTED IN THE HOUSING OF THE DEVICE WHICH PREVENTED MOVEMENT OF THE ROLLER BEARING. THE DEVICE WAS CLEANED AND DISINFECTED AND A NEW ROTOR AND BEARING WERE INSTALLED. A TECHNICAL SAFETY INSPECTION AND FUNCTIONAL CHECK WERE SUCCESSFULLY COMPLETED AND THE DRIVE UNIT WAS RETURNED TO THE CUSTOMER. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) FOUND THAT FLUID HAD LEAKED INTO THE CENTRIFUGAL PUMP DRIVE UNIT CAUSING THE UNIT TO BE NOISY AND ABNORMALLY WARM. THERE WAS NO PATIENT INJURY. THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) FOUND THAT FLUID HAD LEAKED INTO THE CENTRIFUGAL PUMP DRIVE UNIT CAUSING THE UNIT TO BE NOISY AND ABNORMALLY WARM. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463798 CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA SORIN GROUP DEUTSCHLAND GMBH 60-01-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP