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    FDA Adverse Event Malfunction Summary report: N

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    MDR report key: 10097230 · Received May 28, 2020

    Report

    Report Number
    2026095-2020-00072
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Date of Event
    May 7, 2020
    Report Date
    June 25, 2020
    Manufacturer
    AVANOS MEDICAL - IRVINE
    Product Code
    MEB
    UDI-DI
    10680651135664
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: B5: FLOW RATE IS 96 HOURS, NOT 96 ML/HR. USE REVIEW INDICATED PUMP WAS FILLED IN ACCORDANCE WITH THE INSTRUCTIONS, PUMP WAS USED AT NORMAL ROOM TEMPERATURE AND WAS ABOVE CLOTHES OR BLANKETS, CUSTOMER IS NOT CONSIDERED NEW OR INEXPERIENCED, AND THE MEDICATION IS NOT A CONTRIBUTOR TO THE INCIDENT. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. PHOTOS WERE PROVIDED BY THE CUSTOMER; HOWEVER, IT IS NOT POSSIBLE TO IDENTIFY A ROOT CAUSE BASED ON THE PHOTOS. 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.

    Description of Event or Problem · 0

    FLOW RATE IS 96 HOURS, NOT 96 ML/HR.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR LOT 0002970711 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE INVESTIGATION IS IN PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 27 MAY 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 (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    FILL VOLUME: 201 ML, FLOW RATE: 96 ML/HR, PROCEDURE: CHEMOTHERAPY , CATHPLACE: UNKNOWN, INFUSION START TIME: 04-MAY-2020 11:00, INFUSION STOP TIME: (B)(6) 2020 09:00. IT WAS REPORTED THAT THE PATIENT'S PUMP "FINISHED ABOUT 1 DAY EARLIER THAN IT WAS SUPPOSED TO." "PATIENT HAD PUMP ATTACHED ON (B)(6) 2020, THEN PRESENTED TO INFUSION CENTER 1 DAY EARLY AS THE PUMP APPEARED TO BE COMPLETELY EMPTY. THE NURSE CORROBORATED THAT ALL CONNECTIONS, CLAMPS, ETC. WERE CONNECTED PROPERLY AND APPEARED TO BE IN WORKING ORDER. THE PATIENT WILL RETURN TO THE INFUSION CLINIC FOR RE-TREATMENT WITH A NEW PUMP NEXT MONDAY." NO PATIENT INJURY WAS REPORTED. PATIENT WAS EDUCATED ON HOW TO USE THE DEVICE; IT WAS THE PATIENT'S NINTH TIME USING THIS STYLE PUMP. ADDITIONAL INFORMATION WAS RECEIVED 22-MAY-2020 AS FDA MEDWATCH/ FDA USER FACILITY REPORT MW5094439. THE REPORT STATES "PATIENT HAD HALYARD C ELASTOMERIC PUMP ATTACHED FOR 5-FLUOROURACIL EXTENDED INFUSION ON [DATE REDACTED], THEN PRESENTED TO INFUSION CENTER 1 DAY EARLY AS THE PUMP APPEARED TO BE COMPLETELY EMPTY. THE NURSE CORROBORATED THAT ALL CONNECTIONS, CLAMPS, ETC. WERE CONNECTED PROPERLY AND APPEARED TO BE IN WORKING ORDER. THE PATIENT WILL RETURN TO THE INFUSION CLINIC FOR RE-TREATMENT WITH A NEW PUMP NEXT (B)(6). FDA SAFETY REPORT ID [NUMBER REDACTED]."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560423 HOMEPUMP C-SERIES ELASTOMERIC LFR MEB AVANOS MEDICAL - IRVINE C270020 0002970711 10680651135664

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR FLUOROURACIL 20.4MG/ML