BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-Q C-BLOC 400MLX2-14ML/HR WITH 5ML BOLUS

    MDR report key: 3186989 · Received June 19, 2013

    Report

    Report Number
    2026095-2013-00111
    Event Type
    Death
    Date Received
    June 19, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 24, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: AT THIS TIME, I-FLOW IS PURSUING THE SAMPLE, IT IS UNKNOWN IF THE FACILITY WILL RETURN THE UNIT. RESULTS: THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT NUMBER COULD NOT BE OBTAINED. CONCLUSIONS: THIS INCIDENT IS STILL UNDER INVESTIGATION. IF THE SAMPLE IS RETURNED, I-FLOW WILL PERFORM AN EVALUATION AND INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED. 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: ROPIVACAINE 0.2%. FILL VOLUME: 550 ML/HR. FLOW RATE: 10 ML/HR. PROCEDURE: RIGHT MIDFOOT FUSION. CATHPLACE: RIGHT POPLITEAL SCIATIC. DATE OF SURGERY: (B)(6) 2013. PATIENT'S SON CALLED TO REPORT THAT HIS MOTHER HAD FOOT SURGERY ON (B)(6) 2013 AND PASSED AWAY ON (B)(6) 2013. HOSPITAL STATED TO HIM PUMP HAD A FAST FLOW. {ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S SON: (B)(6) 2013} - DURING PATIENT'S DISCHARGE, ON (B)(6), THE PATIENT COLLAPSED ON THE FLOOR. PATIENT WAS TREATED AND TRANSFERRED TO A LEVEL 4 HOSPITAL WHERE SHE WAS TREATED BY PHYSICIANS. ACCORDING TO HER SON, SEVERAL EXAMS WERE PERFORMED TO RULE OUT POSSIBLE CAUSES SUCH AS HEART ATTACK, PULMONARY EMBOLISM ECT. SO HIS BELIEVES THAT THE PUMP DISCHARGED TOO QUICKLY. {ADDITIONAL INFORMATION RECEIVED FROM QUESTIONNAIRE FILLED OUT BY ANESTHESIOLOGIST ON (B)(6) 2013} EXPECTED INFUSION TIME WAS 3 DAYS, INFUSION BEGAN ON (B)(6) 2013 AT 14:10HR. THE PUMP WAS NOT EMPTY AT THE TIME OF DISCONNECT, UNKNOWN VOLUME REMAINING IN THE PUMP. THE DEVICE WAS NOT SAVED FOR RETURN. UNKNOWN IF THE PATIENT RECEIVED THIS MEDICATION IN THE PAST, PATIENT TOLERATED WELL. THE PATIENT EXHIBITED PULSE-LESS ELECTRICAL ACTIVITY, HYPOTENSION. SIDE EFFECTS OCCURRED APPROXIMATELY 22 HOURS AFTER IN PARKING LOT AFTER DISCHARGE. INTERVENTION RECEIVED: CARDIOPULMONARY RESUSCITATION. BLOOD LEVELS WERE NOT DRAWN. UNKNOWN IF THE ADVERSE EVENT WAS RELATED TO THE DEVICE. {ADDITIONAL INFORMATION RECEIVED FROM RISK MANAGER: (B)(4) 2013} PUMP MODEL DESCRIPTION IS ON-Q C-BLOCK 400ML (500ML) VOLUME 2-14ML/HR, SELECT-A-FLOW. UNABLE TO ASCERTAIN THE LOT NUMBER. STILL TRYING TO DETERMINE IF THE PUMP WILL BE AVAILABLE. CAUSE OF DEATH LISTED ON THE CHART: PEA ARREST, ETIOLOGY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279450 ON-Q C-BLOC 400MLX2-14ML/HR WITH 5ML BOLUS ELASTOMERIC PUMP MEB I-FLOW, LLC CB006 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death AND ROPIVACAINE 0.5% 50ML VIA SCIATIC BLOCK NEEDLE| SUPPLEMENTAL PAIN MEDICATIONS RECEIVED BY THE PT:| PRIOR TO PLACING THE CATHETER.| HYDROMORPHONE BY IV PCA| OVER 20 OTHER MEDICATIONS. THE REPORTED| IN ADDITION TO PAIN MEDICATION, THE PT WAS TAKING