BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-Q C-BLOC: 600 ML, 2-14 ML/HR SELECT-A-FLOW

    MDR report key: 3121602 · Received May 16, 2013

    Report

    Report Number
    2026095-2013-00092
    Event Type
    Death
    Date Received
    May 16, 2013
    Report Date
    April 13, 2013
    Manufacturer
    I-FLOW LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE SAMPLE WILL NOT BE RETURNED FOR AN EVAL AND INVESTIGATION. RESULTS: THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. CONCLUSIONS: AT THIS TIME, NO CONCLUSION CAN BE DRAWN. THIS COMPLAINT IS STILL UNDER INVESTIGATION . WHEN THE INVESTIGATION IS COMPLETED, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT. I-FLOW HAS ATTEMPTED TO CONTACT THE DOCTOR SEVERAL TIMES TO FURTHER INVESTIGATE THIS INCIDENT WITH NO RESPONSE. A MESSAGE WAS LEFT WITH THE PHYSICIAN'S SURGICAL ASSISTANT TO HAVE THE DOCTOR RETURN OUR CALLS. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFORMATION, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: 0.5% MARCAINE, FILL VOLUME: 400 ML, FLOW RATE: 14.0 ML/HR, PROCEDURE: DONOR SITE BURN GRAFTING, CATHPLACE: UNK. AN UNIDENTIFIED HOSPITAL PERSONNEL CONTACTED AN I-FLOW SALES REP TO REPORT AN INCIDENT OF (B)(6) BURN PT. THE PT RECEIVED A CB6004 (600 ML) PUMP INSTEAD OF A P400X4D (400 ML) PUMP AFTER SKIN GRAFT SURGERY. THE CB6004 (600 ML) PUMP USED ON THE PT AND WAS FILLED TO 400 ML WITH SAF SET AT 14 ML/HR. IT WAS NOTICED BY A MEDICAL RESIDENT THAT THE VOLUME OF THE PUMP WAS DEPLETED IN 28 HOURS. THE PT WAS GIVEN LIPIDS WHEN THE INCIDENT WAS DISCOVERED. THIS PT CODED AND COULD NOT BE RESUSCITATED. DATE OF DEATH IS UNK AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217747 ON-Q C-BLOC: 600 ML, 2-14 ML/HR SELECT-A-FLOW ELASTOMERIC PUMP MEB I-FLOW LLC 101347600 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death