BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMEPUMP C-SERIES, 270 ML, 5 ML/HR (CONTAINS DEHP)

    MDR report key: 14895471 · Received July 1, 2022

    Report

    Report Number
    2026095-2022-00065
    Event Type
    Injury
    Date Received
    July 1, 2022
    Date of Event
    July 5, 2022
    Report Date
    August 11, 2022
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    MEB
    UDI-DI
    00193494135683
    PMA / PMN Number
    K052117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 01-JUL-2022 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 · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30180804, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF 10-AUG-2022 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 COMPLAINTANT / 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

    FILL VOLUME: 230 ML. FLOW RATE: 5ML/HR. PROCEDURE: CHEMOTHERAPY INFUSION. PUMP START DATE: (B)(6) 2022. PUMP END DATE: (B)(6) 2022 AT 3PM. CATH PLACE: UNKNOWN. IT WAS REPORTED THAT ON DAY-2 OF INFUSION, THE PATIENT EXPERIENCED NAUSEA AND VOMITING. THE NURSE REPORTS FAST FLOW WAS DUE TO THE PUMP BEING EMPTY. THE PATIENT PRESENTED WITH AN INCREASED AMOUNT OF SWELLING IN HIS LEGS SO A DOPPLER STUDY WAS DONE TO CHECK FOR CLOTS, BUT WAS NEGATIVE. ADDITIONAL INFORMATION REQUESTED 10-JUN-2022 STATED THE PATIENT REQUIRED ADDITIONAL INTRAVENOUS (IV) ANTI-NAUSEA MEDICATIONS (ZOFRAN AND DECADRON) AND A LITER OF FLUIDS. "PATIENT IS HOME, CURRENT HEALTH STATUS IS STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2281250 HOMEPUMP C-SERIES, 270 ML, 5 ML/HR (CONTAINS DEHP) ELASTOMERIC LFR MEB AVANOS MEDICAL INC. C270050 30180804 00193494135683

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male 5FU/NS.