BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP C-SERIES 270ML, 5ML/HR

    MDR report key: 4933070 · Received July 22, 2015

    Report

    Report Number
    2026095-2015-00204
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 8, 2015
    Manufacturer
    HALYARD - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    PK052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE DEVICE WAS REPORTED TO BE RETURNING FOR AN EVALUATION AND AT THIS TIME IS PENDING RETURN. THE LOT NUMBER WAS RECEIVED AND A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER REPORTED. RESULTS: AT THIS TIME THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE DEVICE IS RECEIVED, TESTING WILL BE PERFORMED AND RESULTS WILL BE PROVIDED ONCE COMPLETED. HOWEVER, THE DHR WAS REVIEWED FOR THE LOT NUMBER OF THE MANUFACTURED UNIT. THERE WERE NO REWORKS, SPECIAL CONDITIONS, OR RELATED NONCONFORMANCE REPORTS (NCRS) FOR THIS LOT. THE LOT MET THE PROCESS SPECIFICATIONS, INCLUDING THE QUALITY CONTROL ACCEPTANCE CRITERIA PRIOR TO RELEASE. CONCLUSIONS: ONCE THE INVESTIGATION AND DEVICE ANALYSIS 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 INVESTIGATIONS. DEVICE RETURN ANTICIPATED.

    Additional Manufacturer Narrative · 1

    METHOD: THE ACTUAL DEVICE HAS BEEN RECEIVED FOR ANALYSIS. VISUAL OBSERVATION , MICROSCOPIC INSPECTION AND INFUSION VERIFICATION WAS PERFORMED. RESULTS: THE DEVICE WAS REFILLED WITH SALINE AND INFUSION VERIFICATION WAS PERFORMED. WHEN OPENING THE PINCH, INFUSION WAS NOT OBSERVED. NEGATIVE ASPIRATION (SUCTION) WAS APPLIED A FEW TIMES, NO FLOW WAS OBTAINED. THE MALE LUER ADAPTER WAS EXAMINED, AND CRYSTALIZED MEDICATION WAS OBSERVED. THE SAMPLE WAS PLACED IN A HEATED INCUBATOR TO DISLODGE ANY OF THE PARTICULATES. FLOW WAS STILL NOT OBTAINED. NO FLOW WAS OBSERVED FOR THE PUMP DUE TO CRYSTALIZED MEDICATION. CONCLUSION: THE INVESTIGATION SUMMARY CONCLUDES THAT NO FLOW WAS OBSERVED FOR THE PUMP DUE TO CRYSTALIZED MEDICATION AT THE MALE LUER ADAPTER. SEVERAL ATTEMPTS WERE MADE TO REHABILITATE THE PUMP WITHOUT SUCCESS. AS THE DEVICE ANALYSIS CANNOT DETERMINE THE ROOT CAUSE OF THE FLOW ISSUE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. INFORMATION FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT REPORTING SYSTEMS FOR MONITORING, TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    PLEASE REFERENCE: 2026095-2015-00203/15-00644(A), 2026095-2015-00205/15-00658(A) AND 2026095-2015-00206/15-00658(B) FILL VOLUME: 241ML. FLOW RATE: 5ML/HR. PROCEDURE: CHEMOTHERAPY. CATHPLACE: PORT. INFUSION STARTED: (B)(6) 2015 AT 1450. INFUSION ENDED: (B)(6) 2015 AT 0400. IT WAS REPORTED THAT THERE WERE FOUR INCIDENTS WITH FOUR PUMP'S INFUSIONS ENDING SOONER THAN EXPECTED. TWO INCIDENTS OCCURRED WITH THE USE OF THE 270ML PUMPS. INCIDENT #2 OF 2: ADDITIONAL INFORMATION WAS RECEIVED ON 07/08/2015. THE PATIENT RETURNED TO THE CLINIC TO HAVE THE PUMP DISCONNECTED EARLIER THAN SCHEDULED. NO ADVERSE EVENT OCCURRED IN CONNECTION WITH THE REPORTED INCIDENT. THE PATIENT HAD A 9TH CYCLE OF CHEMOTHERAPY. THE DEVICE IS AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477167 HOMEPUMP C-SERIES 270ML, 5ML/HR ELASTOMERIC PUMP MEB HALYARD - IRVINE C270050 0201316744

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR