BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 2053412 · Received March 17, 2011

    Report

    Report Number
    2021710-2011-00021
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. EVENT CODES WERE DERIVED BASED ON INFO DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. (B)(4). CAREFUSION ISSUED A RETURN GOODS AUTHORIZATION (RGA) NUMBER TO THE USER FACILITY FOR THE RETURN OF THE ALLEGED FAULTY PT CIRCUIT FOR EVAL. ADDITIONALLY, A F/U REMINDER TO RETURN THE ALLEGED FAULTY PT CIRCUIT WAS GIVEN TO THE USER FACILITY. AS OF (B)(6) 2011, THE ALLEGED FAULTY PT CIRCUIT HAS NOT BEEN RECEIVED. ONCE THE PT CIRCUIT HAS BEEN RECEIVED AND THE EVAL COMPLETED, A F/U MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH USER FACILITY REP. "[NAME REMOVED] RECALLED TO REPORT THAT THEY FOUND TWO MORE 3100A CIRCUITS (B)(4) THAT JUST "CAME LOOSE" WHILE ON A PT. THE PT DESATURATED AND HAD TO BE MANUALLY HANDVENTILATED WHILE THE TUBING WAS BEING RECONNECTED. THE LOT NUMBERS WERE NOT CHECKED, BUT HE KNOWS THEY WERE OF Y09. I RE-EXPLAINED THAT THE ISSUE HAS RESOLVED (CORRECTIVE ACTION TAKEN ON ASSEMBLY PROCESS) AND THAT THE PROBLEM WAS INTERMITTENT. ALL LOTS PRIOR TO Y11 WOULD BE SUSCEPTIBLE. AGAIN, I STRESSED THAT THE ISSUE IS INTERMITTENT; STOCK WAS NOT PURGED. HE UNDERSTOOD, BUT STATED THAT THEY CANNOT AFFORD TO HAVE THIS KEEP HAPPENING ALL THE TIME. HE STATES THAT THE "TUBE TO THE HUMIDIFIER" JUST "POPS OFF" WITHOUT WARNING. HE STATED THAT HE WISHED TO BE NOTIFIED WHEN ALL OF THE "BAD" STOCK HAD BEEN USED UP. I TOLD HIM THAT I WOULD TRY TO GET HIM AN ETA AND GET BACK TO HIM. HE ONLY HAS ONE CIRCUIT AVAILABLE AT THIS TIME FOR EVAL; THE OTHER WAS THROWN AWAY DUE TO CONTAMINATION. I WILL SEND HIM A BOX OF CIRCUITS (B)(4) AND HAVE THE DEFECTIVE ONE RETURNED UNDER (B)(4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS VENTILATOR, HIGH FREQUENCY / LSZ LSZ CAREFUSION 3100A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ASKU