BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Z C-BLOC 400ML, 2/14ML/HR SAF

    MDR report key: 3957485 · Received June 16, 2014

    Report

    Report Number
    2026095-2014-00088
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: AT THIS TIME I-FLOW IS PENDING THE INVESTIGATION OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER PROVIDED. RESULTS: RESULTS OF THE SAMPLE BEING EVALUATED IS STILL IN PROGRESS. PER THE DHR REVIEW THE LOT MEETS ALL MANUFACTURING SPECIFICATIONS AT RELEASE. CONCLUSIONS: THERE ARE NO RESULTS AS OF YET AS THE SUSPECT DEVICE HAS NOT BEEN EVALUATED. ONCE AN ANALYSIS IS AVAILABLE AND INVESTIGATION IS CONCLUDED A SUPPLEMENTAL REPORT WILL BE ISSUED DOCUMENTING THE FINDINGS. 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

    FILL VOLUME: 400.0 ML. FLOW RATE: 8.0 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. THE PHARMACY REPORTED A PUMP RAN OUT TOO EARLY. IT WAS STARTED ON (B)(6) 2014 AT 9:00 AM AND WAS EMPTIED BY THE MORNING OF (B)(6) 2014. THE PUMP WAS USED FOR A NERVE BLOCK. THE BLOCK LOCATION WAS UNKNOWN. THE INCIDENT WAS NOTICED BY THE ANESTHESIOLOGIST WHILE THE PATIENT WAS IN THE HOSPITAL. THERE WAS NO REPORT OF ADVERSE SIGNS AND SYMPTOMS EXPERIENCED BY THE PATIENT. THE PATIENT WAS REPORTED AS IN GOOD CONDITION. THE PUMP WAS FILLED IN THE OPERATION ROOM USING A SYRINGE. IT WAS FILLED WITH 400ML OF ROPIVACAINE AND SET TO RUN AT 8ML/HR. THE PUMP WAS USED UNDER NORMAL ROOM TEMPERATURE AND HUMIDITY, BUT UNDER A BLANKET. THE SAF UNIT WAS NOT ZIP TIED. THE SAMPLE WAS AVAILABLE FOR RETURN. THREE FOLLOW UPS HAVE NOT BEEN COMPLETED. THE PHARMACY ASSISTANT STATED THAT THE ANESTHESIA MD, BROUGHT A PUMP AND MENTIONED THAT IT "RAN OUT WAY TOO EARLY." CALLER DID NOT KNOW EXACTLY WHAT TIME IT WAS EMPTY BUT SAYS "IT WAS EMPTY BY MORNING OF (B)(6)." THE REPORTER MENTIONED THAT THE PUMPS ARE FILLED IN THE OPERATING ROOM AND THAT "AS FAR AS I KNOW THEY PUT 400 ML IN THE PUMP." IT IS UNKNOWN HOW MANY TIMES SAF RATE WAS CHANGED, IF AT ALL. THE PATIENT WAS FINE AND OTHER INFORMATION WAS NOT DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353009 ON-Z C-BLOC 400ML, 2/14ML/HR SAF ELASTOMERIC PUMP MEB I-FLOW, LLC CB004 0201303299

    Patients

    Seq Age Sex Outcome Treatment
    1 DRUG/DILUENT: 0.2% ROPIVACAINE