BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PUMP 270 ML X 1-7 ML/HR SAF

    MDR report key: 3957476 · Received June 16, 2014

    Report

    Report Number
    2026095-2014-00090
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 20, 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
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: I-FLOW HAS BEEN INFORMED THE SUSPECT DEVICE WILL NOT BE RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER PROVIDED. RESULTS: AS NO DEVICE WAS AVAILABLE FOR AN EVALUATION AND NO METHODS WERE PERFORMED, RESULTS CANNOT BE OBTAINED. PER THE DHR REVIEW THE LOT MEET ALL MANUFACTURING SPECIFICATIONS AT RELEASE. CONCLUSIONS: THE DEVICE WAS NOT RETURNED TO E-FLOW FOR EVALUATION AND ANALYSIS, THEREFORE WE ARE UNABLE TO DETERMINE A CAUSE FOR THE REPORTED EVENT. FURTHER INVESTIGATIONS ARE ONGOING WITH THE REPORTED INFORMATION. IF ADDITIONAL INFORMATION PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT 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

    FILL VOLUME: 335.0ML. FLOW RATE: UNKNOWN. PROCEDURE: KNEE ARTHROSCOPY. CATHPLACE: UNKNOWN. PLEASE REFERENCE 22026095-2014-00089/(B)(4). A COMPLAINT WAS RECEIVED FROM THE SUPERVISOR OF THE PHARMACY, REPORTING THAT TWO PUMPS ON TWO DIFFERENT PATIENTS WERE EXPERIENCING FAST FLOW, AND BOTH PATIENT EXPERIENCED A METAL TASTE IN THEIR MOUTHS. THE PUMP AS FILLED AT THE HOSPITAL PHARMACY ON (B)(6) 2014. IT WAS INFUSED UNDER ROOM TEMPERATURE. THE INCIDENT WAS NOTICED BY THE PATIENT IN THE HOSPITAL. THE PUMP WAS NOT EMPTIED WHEN IT WAS DISCONNECTED FROM THE PATIENT. RESIDUAL VOLUME OF THE PUMP WAS NOT PROVIDED. OTHER PUMP USE CONDITIONS WERE NOT PROVIDED. THE INCIDENT DATES WERE THE SAME FOR THE 2 PUMPS. THESE PUMPS IN QUESTION ARE NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR TESTING. 2026095-2014-00090/(B)(4). PATIENT (B)(6) IS A FEMALE. AGE AND WEIGHT IS NOT PROVIDED. THE INCIDENT DATE WAS (B)(6) 2014. THE PATIENT UNDERWENT KNEE ARTHROSCOPY. THE LOT NUMBER OF THE PUMP IS 0201221123. IT WAS FILLED WITH 335.0ML 0.2% ROPIVACAINE USING A SYRINGE. FLOW RATE AND CATHETER SITE WAS NOT PROVIDED. PATIENT EXPERIENCED A METALLIC TASTE IN THE MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353281 ON-Q PUMP 270 ML X 1-7 ML/HR SAF ELASTOMERIC PUMP MEB I-FLOW, LLC P270X1 0201221123

    Patients

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