BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORMER CPB SUPPORT SYSTEM

    MDR report key: 901801 · Received August 18, 2007

    Report

    Report Number
    3003793891-2007-00002
    Event Type
    Injury
    Date Received
    August 18, 2007
    Date of Event
    July 20, 2007
    Report Date
    July 20, 2007
    Manufacturer
    RAND S.R.L.
    Product Code
    DTQ
    PMA / PMN Number
    K052555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    CCP

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE DEVICE PERFORMED APPROPRIATELY, AS PROGRAMMED. IMPROPER POSITIONING OF THE BUBBLE DETECTOR AND HAVING IT SET TO STOP THE PUMP FOR VENOUS AIR RESULTED IN THE CASCADE OF EVENTS DESCRIBED IN THIS REPORT, WHICH ULTIMATELY RESULTED IN THE STOPPAGE OF FLOW FOR TWO MINUTES. THE BUBBLE DETECTOR MEANT TO STOP THE PUMP FOR ARTERIAL AIR, WHICH IS A MORE SERIOUS SITUATION. THE IFU PROVIDES EXPLICIT INSTRUCTIONS ON THE PROPER PLACEMENT OF COMPONENTS WITHIN THE CIRCUIT TO ENSURE THE SAFETY OF THE PATIENT DURING BYPASS. MEDTRONIC PRODUCT MANAGEMENT EXPLAINED THE ISSUE WITH THE HOSPITAL'S SURGICAL STAFF, WHO HAVE SINCE REPOSITIONED THE ABD TO THE ARTERIAL LINE, AND HAVE SET THE ALARM TO COAST INSTEAD OF PUMP STOP. TO DATE, THERE HAVE BEEN NO SIMILAR REPORTED OCCURRENCES.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS BYPASS CIRCUIT HAD BEEN SET UP IN AN OFF-LABEL CONFIGURATION, WHERE THE AIR BUBBLE DETECTOR/FLOW PROBE HAD BEEN POSITIONED ON THE VENOUS OUTLET OF THE CARDIOTOMY RESERVOIR INSTEAD OF ON THE ARTERIAL SIDE OF THE CIRCUIT. DURING THE CASE, A LOW BLOOD LEVEL ALARM OCCURRED WHICH SENT THE PUMP INTO COAST MODE (AS PROGRAMMED). DUE TO THE POSITION OF THE ABD/FLOW PROBE, AIR WAS DETECTED IN THE CIRCUIT, AND AN AIR BUBBLE ALARM OCCURRED. THIS ALARM CAUSED THE PUMP TO STOP (AS PROGRAMMED). THE PUMP FUNCTIONED NORMALLY, AS IT WAS CONFIGURED. THE PERFUSIONIST ATTEMPTED TO RE-ESTABLISH FLOW, BUT THE PARAMETERS PROGRAMMED WITHIN THE PUMP WOULD NOT ALLOW THE ARTERIAL CLAMP TO OPEN. WITH ASSISTANCE FROM MEDTRONIC PRODUCT MANAGEMENT, FLOW WAS RE-ESTABLISHED. IT WAS REPORTED THAT FLOW HAD STOPPED DURING THE CASE FOR A DURATION OF TWO-MINUTES. IT IS NOT KNOWN AT THIS TIME IF THE PATIENT SUFFERED PERMANENT INJURY DUE TO THE FLOW STOPPAGE DURING THE PROCEDURE. MEDTRONIC HAS REQUESTED DETAILS ON THE PATIENT'S STATUS.

    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 YR Required Intervention