BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMEPUMP C-SERIES: 270 ML, 10ML/HR

    MDR report key: 4396059 · Received January 5, 2015

    Report

    Report Number
    2026095-2014-00302
    Event Type
    Injury
    Date Received
    January 5, 2015
    Report Date
    December 10, 2014
    Manufacturer
    HALYARD
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS RECEIVED FOR ANALYSIS, HOWEVER A CLARIFICATION WAS NECESSARY PRIOR TO ANY TESTING METHODS BEING PERFORMED. A VISUAL INSPECTION WAS PERFORMED AND A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. RESULTS: TWO OF THE THREE PUMPS REPORTED TO BE RETURNING FOR ANALYSIS WERE RECEIVED. ONE PUMP WAS EMPTY AND ONE PUMP WAS FULL. AT THIS TIME CLARIFICATION HAS BEEN REQUESTED FROM THE REPORTER ON THE RETURNED DEVICES. THE DHR WAS REVIEWED FOR THE LOT NUMBER OF THE MANUFACTURED UNIT. THERE WERE NO REWORKS, SPECIAL CONDITIONS, OR RELATED NON CONFORMANCE REPORTS (NCRS) FOR THIS LOT. THE LOT MET THE PROCESS SPECIFICATIONS, INCLUDING THE QUALITY CONTROL ACCEPTANCE CRITERIA PRIOR TO RELEASE. AT THIS TIME HALYARD IS PENDING THE RECEIPT OF CLARIFICATION ON THE PUMPS RECEIVED. AS THE INVESTIGATION IS STILL IN PROGRESS, RESULTS ARE NOT AVAILABLE. ONCE THE CLARIFICATION ONE THE DEVICES IS RECEIVED, TESTING WILL BE PERFORMED ADN RESULTS WILL BE PROVIDED UPON COMPLETION. CONCLUSIONS: ONCE THE ANALYSIS AND INVESTIGATION ARE COMPLETED A FOLLOW-UP REPORT WILL BE SUBMITTED. 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 INVESTIGATION.

    Description of Event or Problem · 1

    FILL VOLUME: UNK - ANP. FLOW RATE: 10 ML/HR. PROCEDURE: UNK - ANP. CATHPLACE: UNK - ANP. A DISTRIBUTOR REPORTED THAT 3 PATIENTS EXPERIENCED FAST FLOW INCIDENTS WHILE USING HOMEPUMPS. THE INCIDENT IS DESCRIBED AS, "SPECIFICALLY 3 PATIENTS HAVE EXPERIENCED DOSES GOING IN 4-7 JOURS TOO FAST FOR WHAT WAS SET UP AS A 24 HOUR INFUSION." PLEASE REFERENCE: 2026095-2014-00300/14-01123(A) AND 2026095-2014-0030114-01123 (B). REPORT 1 OF 3: ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3380 HOMEPUMP C-SERIES: 270 ML, 10ML/HR ELASTOMERIC PUMP MEB HALYARD C270100 0201547459

    Patients

    Seq Age Sex Outcome Treatment
    1 DRUG: UNK