BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMEPUMP ECLIPSE ELASTOMERIC PUMP, 400 ML

    MDR report key: 11150268 · Received January 11, 2021

    Report

    Report Number
    2026095-2021-00005
    Event Type
    Injury
    Date Received
    January 11, 2021
    Report Date
    February 25, 2021
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    MEB
    UDI-DI
    00193494135546
    PMA / PMN Number
    K052117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30079227, 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 (B)(6) 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

    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 (B)(6) 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).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # MW5098016 THE FOLLOWING INFORMATION: FILL VOLUME: 350 ML, FLOW RATE: 100ML/HR, PROCEDURE: ANTIBIOTIC THERAPY, CATHPLACE: UNKNOWN, INFUSION DATE(S): MULTIPLE INFUSIONS (B)(6), ADMINISTERED STARTING (B)(6) 2020, INFUSION TIME OF EACH THERAPY: 3.5 HOURS, START AND STOP TIME: UNKNOWN, (PATIENT SELF ADMINISTERED AT HOME). PATIENT HAD BEEN ON VABOMERE 4GM IV Q8H VIA GRAVITY SINCE (DATE REDACTED)2020 FOR TREATMENT OF PERSISTENT HEPATIC ABSCESSES/BACTEREMIA WITH RESISTANT ORGANISMS STARTING (DATE REDACTED)2020 PATIENT REPORTED RIGHT SIDED FLANK PAIN ASSOCIATED WITH THE END OF HIS INFUSIONS PAIN REPORTEDLY STARTED AFTER HE STARTED USING THE ELASTOMERIC DEVICES DESCRIBES PAIN AS BURNING SENSATION THAT SEEMED TO LESSEN IN SEVERITY AD TIME PROGRESSED AFTER HIS INFUSIONS REPORTS PAIN IS WITH LIGHT TOUCH AND IS 4/10 WHEN HE'S UP AND WALKING NO OTHER SYSTEMIC SIGNS/SYMPTOMS OR RASH NOTED BILIARY DRAIN NOTED TO BE WORKING PROPERLY WITH STABLE LABS (DATE REDACTED)2020 ON (DATE REDACTED)2020. PATIENT WAS SWITCHED BACK TO GRAVITY INFUSIONS FOR REMAINDER OF HIS ANTIBIOTIC THERAPY ON (DATE REDACTED)2020, PATIENT REPORTED THAT PAIN RESOLVED AND THAT HE DID NOT EXPERIENCE ANY FLANK PAIN AFTER SWITCHING BACK TO GRAVITY. ADDITIONAL INFORMATION RECEIVED 17-DEC-2020 STATING THE PHARMACIST STATED THE PUMP FUNCTIONED AS INTENDED AND STATED THE ISSUE COULD BE RELATED TO THE DRUG AND MODE OF THERAPY AND THIS WAS THE FIRST TIME THE DRUG VABOMERE WAS DELIVERED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45687 HOMEPUMP ECLIPSE ELASTOMERIC PUMP, 400 ML ELASTOMERIC HFR MEB AVANOS MEDICAL, INC. E401000 30079227 00193494135546

    Patients

    Seq Age Sex Outcome Treatment
    1 Other VABOMERE 4GM.