BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP ECLIPSE: 400 ML, 100 ML/HR

    MDR report key: 3043053 · Received March 7, 2013

    Report

    Report Number
    2026095-2013-00039
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 5, 2013
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: AT THIS TIME IT IS UNK IF THE DEVICE WILL BE RETURNED TO I-FLOW FOR EVAL AND INVESTIGATION. RESULTS: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER PROVIDED, AND THE DEVICE PASSED ALL MFG SPECIFICATIONS PRIOR TO RELEASE. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED. INFO FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADD¿L INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFO, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: ZOSYN 4.5G IN NORMAL SALINE. FILL VOLUME: 100 ML/HR. PROCEDURE: TREATMENT FOR PSEUDOMONAS PNEUMONIA. CATHPLACE: ANTIBIOTIC TREATMENT. (PLEASE REFERENCE 2026095-2013-00040/13-00184, 2026095-2013-00041/13-000186, AND 2026095-2013-00042/13-00187). PHYSICIAN ORDERED ZOSYN TO BE GIVEN OVER 4 HOURS. PHARMACIST FILLED HOMEPUMP REFERENCE # ((B)(4), 400ML/100ML/HR) TO 400ML¿S. IT RAN OVER 3 HOURS ACCORDING TO THE PATIENT. PATIENT¿S OUTCOME WAS REPORTED TO BE STABLE AND NO ADVERSE EFFECTS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98480 HOMEPUMP ECLIPSE: 400 ML, 100 ML/HR ELASTOMERIC PUMP MEB I-FLOW CORP. 10135540 0200560563

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR