BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP C-SERIES 270ML X 5ML/HR

    MDR report key: 5152199 · Received October 15, 2015

    Report

    Report Number
    2026095-2015-00265
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Report Date
    September 16, 2015
    Manufacturer
    HALYARD - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    PK052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE DEVICES WERE NOT AVAILABLE FOR RETURN, THEREFORE NO TESTING METHODS COULD BE PERFORMED. THE LOT NUMBERS FOR THE SUSPECT DEVICES WERE NOT AVAILABLE; THEREFORE, THE DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU) WAS PERFORMED. RESULTS: AS NO DEVICES WERE RECEIVED, NO TEST METHODS WERE PERFORMED AND TESTING RESULTS CANNOT BE OBTAINED. CONCLUSION: THE DEVICE WAS REPORTED AS NOT AVAILABLE FOR RETURN; THEREFORE, THE ROOT CAUSE FOR THE REPORTED INCIDENTS IS UNKNOWN. LIMITED INFORMATION WAS RECEIVED REGARDING THIS INCIDENT. HOWEVER, IT WAS REPORTED THAT THE DEVICE WAS FILLED TO APPROXIMATELY 250ML OF 5FU. THE NOMINAL FILL VOLUME FOR THIS DEVICE IS 270ML. THE INSTRUCTIONS FOR USE (IFU) PROVIDE A CAUTION IN THE DELIVERY TIME TABLE. FILLING THE PUMP LESS THAN THE LABELED (NOMINAL), VOLUME RESULTS IN FASTER FLOW RATE; FILLING THE PUMP GREATER THAN THE LABELED (NOMINAL), VOLUME RESULTS IN SLOWER FLOW RATE. THE FLOW RATE MAY BE HIGHER OR LOWER THAN ±15% AT THE START AND END OF INFUSION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER NOT YET RECEIVED. WE ARE CURRENTLY INVESTIGATING THIS COMPLAINT THEREFORE, A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED. A TECHNICAL BULLETIN WILL BE SENT TO THE CUSTOMER REGARDING FACTORS THAT MAY AFFECT FLOW RATE. THIS INCIDENT HAS BEEN INCLUDED IN OUR COMPLAINT HANDLING DATABASE FOR MONITORING AND TRENDING PURPOSES. NOT RETURNED TO MFG.

    Additional Manufacturer Narrative · 1

    CONCLUSION: FURTHER INFORMATION WAS REQUESTED HOWEVER, NOT RECEIVED. THE ONLY RESPONSE THAT WAS PROVIDED BY THE REPORTER WAS THAT ¿UNTIL NOW NO PATIENT HAVE BEEN HARMED BY USING THE HOME PUMP IN THIS HOSPITAL." LOT INFORMATION WAS NOT AVAILABLE THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. A REVIEW OF THE INSTRUCTIONS FOR USE AND A USER REVIEW WAS PERFORMED. PER THE INSTRUCTIONS FOR USE (IFU) THERE ARE SEVERAL FACTORS THAT MAY AFFECT THE FLOW RATE INCLUDING FILL VOLUME, TEMPERATURE, VISCOSITY OF THE DRUG SOLUTION, PUMP POSITION, STORAGE TIME AND EXTERNAL PRESSURE. TEMPERATURE WILL AFFECT SOLUTION VISCOSITY, RESULTING IN FASTER OR SLOWER FLOW RATE. ¿ THE FLOW CONTROLLER (LOCATED DISTAL TO THE FILTER) SHOULD BE CLOSE TO, OR IN DIRECT CONTACT WITH THE SKIN (31°C/88°F). ¿ THE TUBING SHOULD GO UNDER THE PATIENT¿S CLOTHING. ¿ FLOW RATE WILL INCREASE APPROXIMATELY 1.4% PER 0.6°C/1°F INCREASE IN TEMPERATURE AND WILL DECREASE APPROXIMATELY 1.4% PER 0.6°C/1°F DECREASE IN TEMPERATURE. ¿ IF STORED IN THE REFRIGERATOR OR FREEZER, ALLOW PUMP TO REACH ROOM TEMPERATURE BEFORE USING. IT MAY TAKE SEVERAL HOURS FOR A PUMP TO REACH ROOM TEMPERATURE, DEPENDING ON FILL VOLUME. (TABLE 1) ¿ TO ENSURE FLOW RATE ACCURACY, DO NOT PLACE HEAT OR COLD THERAPY IN CLOSE PROXIMITY TO THE FLOW CONTROLLER TUBING. THOUGH THE ACTUALLY AMBIENT TEMPERATURE WAS GIVEN (THE DESCRIPTION OF THE TEMPERATURE AS HOT) AN INCREASE IN TEMPERATURE CAN CONTRIBUTE TO THE FLOW OF INFUSING MEDICATION. IT IS REASONABLE TO DEDUCE THAT THE HOT AMBIENT TEMPERATURE IS A CONDITION THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT OF FAST FLOW. IN ADDITION, THE NOMINAL FILL VOLUME FOR THIS DEVICE IS 270ML. THE REPORTER STATES THAT THE DEVICE WAS FILLED TO 250MLS. PER THE TABLE PROVIDED IN THE IFU A FILL VOLUME OF 244MLS WILL GIVE AN APPROXIMATE DELIVERY TIME OF 48 HOURS. THE EXACT EXPECTED TIME OF INFUSION WAS NOT PROVIDED ALONG WITH THE START AND STOP TIMES, THEREFORE CALCULATIONS CANNOT BE PERFORMED TO DETERMINE APPROXIMATE DELIVERY TIME. AS THE DEVICE WAS NOT RETURNED TO HALYARD FOR AN EVALUATION A CAUSE FOR THE EVENT CANNOT BE DETERMINE. A TECHNICAL BULLETIN, FACTORS AFFECTING FLOW RATE (CSERIES) WAS SENT TO THE CUSTOMER. INFORMATION FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    {PLEASE REFERENCE REPORTS 2026095-2015-00249 - 2026095-2015-00268, (B)(4)} 20 TOTAL PATIENTS, PATIENT 17 OF 20: IT WAS REPORTED BY OUR FOREIGN DISTRIBUTOR THAT THERE WERE 20 PATIENTS WHO EXPERIENCED FASTER FLOW. THE INFUSION TIME WAS BETWEEN 12-16 HOURS LESS THAN EXPECTED, THE PUMPS WERE FINISHED AFTER 33 HOURS. IT IS UNKNOWN IF SAMPLES WILL BE AVAILABLE FOR TESTING. IT WAS REPORTED THAT "NO PATIENTS WERE HARMED." NO FURTHER INFORMATION HAD BEEN REPORTED, HOWEVER IT HAS BEEN REQUESTED. FILL VOLUME: 250ML; FLOW RATE: 5ML/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682846 HOMEPUMP C-SERIES 270ML X 5ML/HR ELASTOMERIC PUMP MEB HALYARD - IRVINE C270050 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1