BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARNS CENTRIFUGAL PUMP

    MDR report key: 1832640 · Received March 3, 2008

    Report

    Report Number
    1124841-2008-00004
    Event Type
    Injury
    Date Received
    March 3, 2008
    Date of Event
    February 4, 2008
    Report Date
    February 14, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE HAS NOT BEEN RETURNED FOR EVAL WHICH RESTRICTS OUR ABILITY TO CONDUCT A THOROUGH INVESTIGATION. THE DEVICE WAS MADE AVAILABLE FOR VISUAL EXAMINATION AT THE (B)(6) MEDICAL CENTER. EXAMINATION OF THE DEVICE DETERMINED THAT THERE WAS PRESENCE OF BLOOD INTERNALLY ON BOTH THE TOP AND BACK SIDE OF THE UNIT, INDICATING A LACK OF SEAL OR COMPRESSION. THE IMPELLER WAS OBSERVED TO BE DISLODGED FROM THE MAGNET ROTOR SHAFT. MAGNIFIED INSPECTION OF THE DEVICE USING A LAPAROSCOPIC INSTRUMENT REVEALED THE SHAFT TO BE BROKEN JUST UNDERNEATH THE IMPELLER. WITHOUT THE ABILITY TO FURTHER DISASSEMBLE THE DEVICE, THE CAUSE FOR THE REPORTED FAILURE CANNOT BE DETERMINED. RETENTION SAMPLES HAVE BEEN VISUALLY EXAMINED WITH NO ABNORMALITIES. THE DEVICE HISTORY RECORD DID NOT INDICATE ANY PRODUCTION RELATED PROBLEMS. A REVIEW OF THE COMPLAINT RECORDS CONFIRMED THAT THIS LOT NUMBER HAS NOT BEEN REPORTED PREVIOUSLY FOR THIS ISSUE. A F/U MDR WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE. ADDITIONAL INFO FROM THE USER FACILITY REPORT: (B)(4).

    Description of Event or Problem · 1

    REFER TO THE ATTACHED USER FACILITY MEDWATCH REPORT ((B)(4)) FOR THE USER FACILITY'S DESCRIPTION OF THE REPORTED EVENT. THIS ADDITIONAL INFO WAS OBTAINED THROUGH FOLLOW-UP DISCUSSIONS WITH THE USER FACILITY, BUT HAS NOT BEEN INDEPENDENTLY DETERMINED: THE USER FACILITY REPORTED THAT ARTERIAL FLOW DROPPED FROM 6.5 L/MIN TO 0.0-0.3 L/MIN, WITH AN INTERMITTENT BACKFLOW ALARM FROM THE FLOW SENSOR. THEY ALSO REPORTED THE USER REPLACED THE PUMPHEAD WITH TUBING AND SWITCHED TO A ROLLER PUMP AS ARTERIAL PUMP. THIS STEP RESTORED ARTERIAL FLOW FOR THE REMAINDER OF THE CASE. THE USER FACILITY ESTIMATES THAT ARTERIAL FLOW WAS INTERRUPTED FOR 15-20 MINUTES. THE USER FACILITY HAS DECLINED TO PROVIDE STATUS UPDATES ON THE PT CONDITION. ADDITIONAL INFO FROM THE USER FACILITY REPORT: CENTRIFUGAL PUMP FAILURE DURING CABG OPERATION. THE MAGNETIC MOTOR DRIVE COUPLING DEVICE SEPARATED FROM THE IMPELLER MAGNET, RESULTING IN FAILURE. MAGNET INSIDE THE DISPOSABLE PUMPHEAD SEPARATED FROM THE IMPELLER, RESULTING IN COMPLETE LOSS OF FORWARD FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARNS CENTRIFUGAL PUMP CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. DELPHIN HK-06

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization