BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORMER CPB SUPPORT SYSTEM

    MDR report key: 1315467 · Received February 6, 2009

    Report

    Report Number
    3003793891-2009-00001
    Event Type
    Injury
    Date Received
    February 6, 2009
    Date of Event
    January 9, 2009
    Report Date
    February 26, 2009
    Manufacturer
    RAND S.R.L.
    Product Code
    DTQ
    PMA / PMN Number
    K052555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: A FIELD SERVICE TECH PERFORMED FUNCTIONAL TESTING OF THE INSTRUMENT. THE INSTRUMENT PERFORMED NORMALLY THROUGHOUT TESTING, OPERATING AS DESIGNED. AS A PRECAUTIONARY MEASURE, THE PM1 ROLLER HEAD WAS REMOVED AND REPLACED. CONCLUSION: FUNCTIONAL TESTING OF THE INSTRUMENT DID NOT IDENTIFY ANY ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE PM1 MOTOR FROM NOT BEING ABLE TO TURN ON ITS OWN. THE USER REVIEWED THE ANALYSIS REPORT AND WAS SATISFIED THAT THE INSTRUMENT WAS FUNCTIONING APPROPRIATELY. ADDITIONAL INFO FROM THE USER INDICATED THE INCIDENT WAS A MGMT ISSUE AND NOT AN EQUIPMENT ANOMALY. MEDICAL AND SURGICAL INTERVENTION WAS USED TO EMPTY THE HEART AFTER SUBSEQUENT FIBRILLATION, DUE TO LV DISTENTION. THE PT FULLY RECOVERED POST-OPERATIVE AND DID NOT DEMONSTRATE ANY ILL EFFECTS FROM THE PERIOD OF LV DISTENSION DURING SURGERY. A REVIEW OF COMPLAINTS DID NOT IDENTIFY ANY TRENDS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT DURING THE CABG PROCEDURE WITH A LARGE MALE PT, AS THE CROSS CLAMP WAS REMOVED, THE LEFT VENTRICLE (LV) WAS NOT ABLE TO BE EMPTIED. THE HEART DEFIBRILLATED SPONTANEOUSLY AND BEGAN TO DISTEND AND HIGH NEGATIVE VLP SPIKES AND ALARMS WERE OBSERVED. THE BLOOD FLOW WAS MANIPULATED, BUT CONTINUED TO OBSERVE THE HIGH NEGATIVE VLP SPIKES, DESPITE THE PHYSICIAN CONFIRMING THE RIGHT ATRIUM WAS FULL. THE LV CONTINUED TO DISTEND UNTIL THE HEART FIBRILLATED. THE PHYSICIAN PLACED A SECOND VENT LINE WHICH WAS ADDED TO THE PM1 ROLLER OF THIS INSTRUMENT, HOWEVER, AFTER THE ADDITION OF THE SECOND LINE COULD NOT TURN ON ITS OWN. THE TUBING PLACEMENT IN THE ROLLER WAS VERIFIED AND THE USER HAND CRANKED A FEW TIMES TO ENSURE THE TUBING WAS NOT BINDING. THE PM1 ROLLER WOULD STILL NOT TURN UNDER IT'S OWN POWER. EVENTUALLY, THE PM1 ROLLER DID START TO TURN ON IT'S OWN. IN THE MEANTIME, THE PHYSICIAN MADE AN INCISION IN THE LV AND USED A CELL WASHER SUCKER TO EMPTY THE CHAMBER. AFTER THE LV WAS EMPTY, THE HEART WAS DEFIBRILLATED AND NORMAL BLOOD FLOW WAS ACHIEVED. THE PT WAS SUCCESSFULLY WEANED FROM BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORMER CPB SUPPORT SYSTEM DTQ RAND S.R.L. R5100052 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention WAS A MODEL 36/46 MFG BY EDWARDS LIFESCIENCE.| THE VENOUS CANNULA USED IN THIS CABG PROCEDURE