BEUDAMED
    FDA Adverse Event Other Summary report: N

    SORIN AF 620 W/LOOP 10

    MDR report key: 1741471 · Received June 25, 2010

    Report

    Report Number
    1718850-2010-00116
    Event Type
    Other
    Date Received
    June 25, 2010
    Date of Event
    May 27, 2010
    Report Date
    May 28, 2010
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWE
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURERS THE ARTERIAL FILTER. THE ARTERIAL FILTER IS A COMPONENT OF THE SORIN AF620 WITH/LOOP 10 PACK. THE 510(K) NUMBER FOR THE ARTERIAL FILTER IS K093986. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE PERFUSIONIST HAD REPORTED THAT THERE WAS A LOSS OF FLOW THROUGH THE FILTER. THE FILTER WAS RETURNED TO THE SORIN GROUP (B)(4). VISUAL INSPECTION OF THE FILTER AND BYPASS LOOP REVEALED SOME RESIDUAL BLOOD IN THE CIRCUIT, BUT NO CLOTS OR CLOTTING WERE SEEN. THE FILTER WAS RETURNED TO THE SORIN GROUP (B)(4) FOR EVALUATION. THEY RESPONDED THAT DURING FUNCTIONAL TESTING, THE DEVICE SHOWED A SIGNIFICANT INCREASE IN PRESSURE DROP VALUES. UPON AUTOPSY, PLATELET AND FIBRIN DEPOSITION WAS NOTED ON THE FILTER MEDIA AND NETTING. IN ADDITION, THE FILTER NETTING SHOWED EVIDENCE OF PORE OCCLUSION. A F/U REPORT WILL BE FILLED WHEN ADDITIONAL INFORMATION IS AVAILABLE. THERE WAS NO REPORT OF PT INJURY. HOWEVER, THE PT WAS DE-CANNULATED AND REMOVED FROM BYPASS. THIS MEDWATCH REPORT IS FILED AS A RESULT OF THIS ACTION.

    Description of Event or Problem · 1

    THE PERFUSIONIST REPORTED THAT AT THE ONSET OF BYPASS, BLOOD FLOW THROUGH THE ARTERIAL FILTER WOULD NOT GO ABOVE 2.5 LPM DUE TO LINE PRESSURES OF GREATER THAN 300 MMHG. THEY INFORMED THE SURGEON AND CAME OFF CPB. THE SURGEON REPLACED THE AORTIC CANNULA AND THEY ATTEMPTED TO GO BACK ON CPB A SECOND TIME. AT THIS TIME, THERE WAS NO FLOW FROM THE CIRCUIT TO THE PT. THE SURGEON DISCONNECTED BOTH THE ARTERIAL AND VENOUS LINES FROM THE PT AND CONNECTED THEM TOGETHER TO ALLOW THE PERFUSIONIST TO RECIRCULATE BLOOD DURING TROUBLESHOOTING. THE PERFUSIONIST ISOLATED THE ARTERIAL FILTER AND USED THE BYPASS LOOP TO ATTEMPT FORWARD FLOW. IMMEDIATELY, FULL FLOW WAS OBTAINED GOING THROUGH THE BYPASS LOOP WITH THE FILTER CLAMPED OUT. THE FILTER WAS CHANGED OUT. THE SURGEON RE-CONNECTED THE LINES TO THE PT AND THEY WENT ON FULL CPB SUCCESSFULLY. THE PERFUSIONIST REPORTED THAT THE PT WAS FOLLOWING THE NORMAL POST-OP COURSE AND WAS "NEUROLOGICALLY INTACT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SORIN AF 620 W/LOOP 10 CUSTOMER PERFUSION PACK DWE SORIN GROUP USA, INC. NA 1011600002

    Patients

    Seq Age Sex Outcome Treatment
    1