BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-Q C-BLOC: 400ML, 2-14ML/HR, SAP

    MDR report key: 3550295 · Received December 23, 2013

    Report

    Report Number
    2026095-2013-00188
    Event Type
    Death
    Date Received
    December 23, 2013
    Date of Event
    November 27, 2013
    Report Date
    November 27, 2013
    Manufacturer
    I-FLOW LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR AN EVALUATION AND INVESTIGATION. A LOT NUMBER WAS NOT PROVIDED FOR THE DEVICE, THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. CONCLUSIONS: AT TIS TIME I-FLOW IS CONTINUING TO INVESTIGATE THIS INCIDENT. FURTHER INFORMATION WILL BE PROVIDED IN A FOLLOW-UP REPORT. 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: 0.2% ROPIVACAINE. FILL VOLUME: UNK, FLOW RATE: STARTED AT 6ML/HR MOVED UP TO 10ML/HR, PROCEDURE: ARTHROPLAST, CATHPLACE: FACIA-ILIAC BLOCK, DATE OF SURGERY: (B)(6) 2013. PATIENT HAD HIP FRACTURE AND HAD A ARTHROPLASTY ON (B)(6). AFTER SURGERY, PUMP C8004 WITH 0.2% ROPIVACAINE WAS CONNECTED TO CATHETER AT FACIA-ILIAC BLOCK. SURGERY WENT WELL AT 6-6:30PM PATIENT COMPLAINED ABOUT PAIN SO THE FLOW RATE WAS DIALED UP FROM 6-10 ML/HR. PATIENT IS VERY ILL AND HAS TURNER SYNDROME. MD THINKS THE PUMP WORKED FINE WITHOUT MALFUNCTION. PATIENT PASSED AWAY THE NEXT MORNING. IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY DRUG RELATED SYMPTOMS OR SIDE EFFECTS. EXACT DATE OF DEATH, PATIENT AGE AND WEIGHT WAS NOT PROVIDED. ADDITIONAL INFORMATION RECEIVED (B)(4) 2013 PER THE ANESTHESIOLOGIST: FEMALE PATIENT WAS VERY ILL, ELDERLY IN HER (B)(6), SHORT AND WEIGHT ABOUT (B)(6), WITH TURNER SYNDROME AND CONGESTIVE HEART FAILURE. SHE HAD AN ARTHROPLASTY ON (B)(6) 2013. AFTER SURGERY, PATIENT RECEIVED A SINGLE BOLUS 0.2% ROPIVACANIEN AT FASCIA-ILLACA BLOCK, CATHETER WAS PLACED AROUND HER HIP (CANNOT RECALL RIGHT OR LEFT HIP) AND THEN THE CB004 PUMP WITH 0.2% ROPIVACAINE WAS CONNECTED AT THE RECOVERY ROOM IN THE EVENING. DAY 1 POST-OP ((B)(6) 2013), ANESTHESIOLOGIST FOLLOWED UP WITH THE PATIENT IN THE EVENING. SHE WAS DOING OKAY JUST COMPLAINED ABOUT STILL PAINFUL AROUND HER HIP AREA/SURGICAL SITE. THE FLOW RATE OF THE PUMP WAS DIALED UP FROM 6ML/HR TO 10ML/HR. PUMP WAS CARRIED IN A BLACK BAG AROUND HER LAP WHEN SHE WAS SITTING DOWN AT NORMAL ROOM TEMPERATURE. THE PATIENT WA ALSO ON SOME ORAL PAIN MEDS AT THE TIME. PATIENT WAS FOUND PASSED AWAY IN THE MIDDLE OF THE NIGHT. PUMP AND CATHETER WERE DISCARDED. ANESTHESIOLOGIST STATED THAT HE IS NOT SURE ABOUT THE CAUSE OF DEATH BUT THERE IS NO SIGNS OF MALFUNCTION OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672555 ON-Q C-BLOC: 400ML, 2-14ML/HR, SAP ELASTOMERIC PUMP MEB I-FLOW LLC CB004 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ORAL PAIN MEDICATION NAME AND DOSAGE NOT PROVIDED