BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP C-SERIES, 270 ML, 2 ML/HR (CONTAINS DEHP)

    MDR report key: 9315579 · Received November 13, 2019

    Report

    Report Number
    2026095-2019-00181
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    October 11, 2019
    Report Date
    January 15, 2020
    Manufacturer
    AVANOS MEDICAL - IRVINE
    Product Code
    MEB
    UDI-DI
    30680651135668
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 0203055288, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE DEVICE WAS EVALUATED. A FLOW RATE ACCURACY TEST WAS PERFORMED AND THE DEVICE WAS WITHIN SPECIFICATIONS. THE EVALUATION SUMMARY CONCLUDED THE PUMP'S DISTAL LUER END INFUSED DURING INFUSION VERIFICATION. THE REPORTED FAILURE WAS NOT CONFIRMED. NO ROOT CAUSE WAS IDENTIFIED ALL INFORMATION REASONABLY KNOWN AS OF (B)(6)2020 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4) . THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. - ATTACHMENT: [MW 5091408.PDF]

    Description of Event or Problem · 0

    FDA MEDWATCH MW5091408 RECEIVED STATING (PHARMACIST REPORTS): AVANOS HOMEPUMP C-SERIES PUMP INFUSED IN TOO QUICKLY. THE PT WAS STARTED O MONDAY AND DE-ACCESSED ON THE FRIDAY. THERE SHOULD HAVE BEEN ENOUGH DRUG IN THE PUMP FOR (B)(4) ADD'L DAY AS THE PUMP WAS FILLED FOR (B)(4) DAYS. THIS INCIDENT ALSO OCCURRED ON (B)(4) SUBSEQUENT TREATMENTS EACH INCIDENT WAS REPORTED TO THE COMPANY. THE COMPANY SENT RETURN BOXES TO RETRIEVE THE PUMPS FOR TESTING PURPOSES TO DATE NO TESTING INFO HAS BEEN FORWARDED TO OUR FACILITY FOR REVIEW. I FOLLOWED UP WITH THE COMPANY BUT THEY DID NOT HAVE ANY INFO CONCERNING THE THREE PUMPS. THE ADDITIONAL INCIDENTS REFERENCED WERE PREVIOUSLY REPORTED IN MEDWATCH REPORTS 2026095-2019-00183, 2026095-2019-00184 AND 2026095-2019-00186.

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. UPON COMPLETION OF THE SAMPLE EVALUATION AND INVESTIGATION; A FOLLOW-UP REPORT WILL BE FILED. ALL INFORMATION REASONABLY KNOWN AS OF 08-NOV-2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    FILL VOLUME: 243CC. FLOW RATE: 2ML/HR. PROCEDURE: CHEMOTHERAPY. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PATIENT'S PUMP WAS SUPPOSED TO INFUSE IN 120-HOURS BUT THE PATIENT CAME IN ON FRIDAY MORNING AND THE PUMP WAS EMPTY. THE PUMP EMPTIED 24-HOURS EARLY ACCORDING TO THE PHARMACY. THE PATIENT WAS STABLE WITH NO SIDE EFFECTS FROM THE MEDICATION INFUSING IN TOO FAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109758 HOMEPUMP C-SERIES, 270 ML, 2 ML/HR (CONTAINS DEHP) ELASTOMERIC LFR MEB AVANOS MEDICAL - IRVINE C270020 0203055288 30680651135668

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 5FU