BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP C-SERIES: 100 ML, 2 ML/HR

    MDR report key: 3577039 · Received November 14, 2013

    Report

    Report Number
    2026095-2013-00167
    Event Type
    Malfunction
    Date Received
    November 14, 2013
    Date of Event
    September 24, 2013
    Report Date
    October 16, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: AT THIS TIME THE DEVICE IS PENDING RETURN FOR AN INVESTIGATION AND EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER PROVIDED. RESULTS: THE EVALUATION HAS NOT BEEN PERFORMED AS THE DEVICE IS PENDING RECEIPT. THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS AT RELEASE. CONCLUSIONS: FURTHER INVESTIGATIONS ARE CURRENTLY BEING PERFORMED WITH THE REPORTED INFORMATION. THE DEVICE WILL BE EVALUATED ONCE RECEIVED. 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 MOR 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: GLUCOSE 5%/5FU. FILL VOLUME: 96 ML. FLOW RATE: 2 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: IMPLANTABLE CHAMBER. (SUMMARY): A FAST FLOW WAS REPORTED, THE PUMP WAS EMPTY WITHIN 24 HOURS. (INCIDENT AS REPORTED): ADD'L PUMP PLACED ON (B)(6) 2013 AND GOT EMPTY WITHIN 24 HOURS. PATIENT'S WEIGHT WAS REPORTED AS UNKNOWN. START OF INFUSION: (B)(6) 2013 @ 06:30PM END OF INFUSION: TIME NOT REPORTED. RECEIVED 10/30/2013 ENDED ON (B)(6) 2013 @ 06:30PM. (ADDITIONAL INFORMATION RECEIVED 10/30/2013): THERE WAS NO INJURY OR SPECIFIC SYMPTOMS RELATED TO THE PATIENT. PATIENT'S WEIGHT IS UNKNOWN AS THERE IS NO TRACEABILITY OF THIS INFORMATION IN THE FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592101 HOMEPUMP C-SERIES: 100 ML, 2 ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC C100020 0200865984

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR