BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP C-SERIES, 100 ML, 2 ML/HR (CONTAINS DEHP)

    MDR report key: 12131799 · Received July 7, 2021

    Report

    Report Number
    2026095-2021-00072
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    June 9, 2021
    Report Date
    August 30, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    MEB
    UDI-DI
    00193494135614
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT 20039759 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. THE SAMPLE EVALUATION DETERMINED THE REPORTED EVENT OF "FAST FLOW" WAS CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED; HOWEVER TWO POSSIBLE CONTRIBUTORS INCLUDE THE MEDICATION INFUSED AND THE DEVICE USING A 5ML/HR FLOW RESTRICTOR INSTEAD OF 2ML/HR FLOW RESTRICTOR. ALL INFORMATION REASONABLY KNOWN AS OF 26 AUG 2021 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 COMP-GHC-21-01825. 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.

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. THE INVESTIGATION REMAINS IN PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 16 AUG 2021 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.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. ALL INFORMATION REASONABLY KNOWN AS OF 07 JUL 2021 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. 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: 93ML. FLOW RATE: UNKNOWN. PROCEDURE: CHEMOTHERAPY. CATHPLACE: UNKNOWN. INFUSION START TIME: (B)(6) 2021 14:44. INFUSION STOP TIME: (B)(6) 2021 0900. IT WAS REPORTED THAT THE PUMP DELIVERED MEDICATION THREE TIMES FASTER THAN INTENDED. HOSPITAL PERFORMED AN INJECTION OF NEULASTA FOR RECOVERY OF WHILE BLOOD CELL LEVELS IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED 17-JUN-2021 INDICATED THE INCIDENT WAS "RAPID INJECT OF ANTICANCER DRUG." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029007 HOMEPUMP C-SERIES, 100 ML, 2 ML/HR (CONTAINS DEHP) ELASTOMERIC LFR MEB AVANOS MEDICAL INC. C100020 20039759 00193494135614

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR FLUOROURACIL