BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ON-Q PAIN PUMP

    MDR report key: 20294692 · Received September 24, 2024

    Report

    Report Number
    2026095-2024-00049
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    July 2, 2024
    Report Date
    September 24, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    MEB
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 24 SEP 2024 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL 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

    IT WAS REPORTED VIA FDA MEDWATCH MW5158240, ¿DEAR SIR/MADAM MY WIFE HAD KNEE SURGERY AND THE SURGEON INSTALLED A NERVE BLOCK INFUSION PUMP SOLD BY (B)(6). THE SURGERY WAS PERFORMED EARLY IN THE MORNING. SHE WAS RELEASED LATER THAT DAY, TAKEN HOME AND PLACED IN BED REST. THE NEXT MORNING HER NIGHT CLOTHES, BED COVERS AND FLOOR CARPET ALONG THE SIDE OF THE BED WERE WET. THE DRESSING OVER THE WOUND ALSO HAD FAILED FROM THE MEDICATION LEAKING BETWEEN IT AND THE CLOSED WOUND. I CALLED (B)(6) AND WAS GIVEN THE FLIPPANT ANSWER TO REDRESS THE WOUND. THE INSTRUCTIONS PROVIDED WITH THE PUMP INDICATE IT WILL "LAST FOR 2-3 DAYS". MY WIFE WAS IN PAIN ALL THE TIME THIS PUMP WAS TO BE IN SERVICE. SINCE A HOME HEALTH NURSE WAS DUE LATER IN THE DAY WE DID NOT ATTEMPT TO REDRESSES A 7 INCH SURGICAL OPENING. THE HOME HEALTH RN REMOVED THE WET DRESSING AND INDICATED SOMETHING HAD TO BE DONE REGARDING THE LEAK AT THE INJECTION SITE OR HER DRESSING WOULD COME LOOSE. I INFORMED HER I HAD CALLED AND THEY HAD FLIPPED ME OFF. SHE THEN CALLED AND THEY GAVE HER THE SAME ANSWER, ONLY MORE LONG WINDED. PART OF THE ANSWER TO HER WAS TO REDUCE THE FLOW. THE PATIENT ALREADY WAS NOT RECEIVING THE SURGEONS PRESCRIBED DOSE DUE TO THE POOR DELIVER SYSTEM. THEIR (NONE MEDICAL) FIX WAS TO REDUCE THE FLOW AND HOPED THE PATIENT WOULD RECEIVED ENOUGH MEDICATION. WITHOUT REMOVING THE DELIVERY NEEDLE THE RN ATTEMPTED TO BETTER SEAT IT AND REDRESSED IT IN AN ATTEMPT TO HOLD IT IN PLACE. LATER THAT DAY HER GOOD WORK WAS TO NO AVAIL TO ALLOW A POORLY DESIGNED DELIVER UNIT TO FUNCTION PROPERLY. A POORLY DESIGNED DELIVERY SYSTEM SHOULD NOT BE SOLD TO THE PUBLIC AND CAUSE THE PATIENT TO SUFFER AT THE SELLERS PROFIT. ALSO THE SELLER SHOULD NOT BE ALLOWED TO MAKE MEDICAL JUDGMENTS SUCH AS REDUCING THE FLOW FOR MEDICATION PRESCRIBED BY THE SURGEON. (B)(6).¿ WOUND DEHISCENCE REPORTED IN HEALTH EFFECT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091447 UNKNOWN ON-Q PAIN PUMP ELASTOMERIC HFR MEB AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Other