BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PUMP WITH SELECT-A-FLOW

    MDR report key: 9717599 · Received February 17, 2020

    Report

    Report Number
    2026095-2020-00025
    Event Type
    Injury
    Date Received
    February 17, 2020
    Date of Event
    January 25, 2020
    Report Date
    May 8, 2020
    Manufacturer
    AVANOS MEDICAL - IRVINE
    Product Code
    MEB
    UDI-DI
    10680651134728
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT 0002976702 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 08 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 COMPLAINT COMP-GHC-20-00306. 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. ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 17 FEB 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. 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: 540 ML. FLOW RATE: 8 ML/HR. PROCEDURE: HYSTERECTOMY. CATHPLACE: SUPERIOR TO PELVIC SYMPHYSIS. INFUSION START TIME: (B)(6) 2020 14:00. INFUSION STOP TIME: (B)(6) 2020 22:00. IT WAS REPORTED THAT THE PATIENT CAME "TO THE EMERGENCY DEPARTMENT AND WAS ADMITTED TO THE HOSPITAL. [THE PATIENT] COMPLAINED OF ABDOMINAL PAIN AND WAS FOUND TO HAVE A FEVER." THE USER FACILITY STATED THAT IT WAS BELIEVED THE PATIENT "MAY HAVE HAD A POSSIBLE PELVIC INFECTION RELATED TO THE PUMP." ADDITIONAL INFORMATION RECEIVED 30-JAN-2020 INCLUDED PATIENT DEMOGRAPHICS. THE TREATMENT/INTERVENTION PERFORMED WAS "BROAD-SPECTRUM ANTIBIOTICS TREATMENT." PATIENT OUTCOME WAS LISTED AS "RECOVERED." PATIENT DIAGNOSIS WAS "POSTOPERATIVE FEVER" WITH SYMPTOMS OF GENERALIZED ABDOMINAL PAIN, CHILLS, TREMORS, MILD FEVER. THE PHYSICIAN "BELIEVES THE [DEVICE] MAY POSSIBLY BE RELATED TO THE POST-OPERATIVE FEVER RESULTING IN HOSPITALIZATION. THE PATIENT EXPRESSED A DECREASE IN SYMPTOMS TEMPORARILY UPON REMOVAL OF THE CATHETER. POST-OPERATIVE INFECTIONS DO NOT TYPICALLY OCCUR AS EARLY AS THIS PATIENT'S INCIDENT." "APPROXIMATELY 48 HOURS AFTER THE PUMP WAS PLACED, AT AROUND 6PM ON (B)(6) 2020 THE PATIENT EXPERIENCED CHILLS AND TREMORS AND SUSPECTED A FEVER WHILE AT HOME. SHE TOOK HER TEMPERATURE AT THIS TIME AND HAD A MINOR TEMPERATURE ELEVATION OF 99.4F. SHE HAD GENERALIZED ABDOMINAL PAIN WHICH WAS NOT RELIEVED BY OXYCODONE, IBUPROFEN OR TYLENOL. SHE DENIES REDNESS OR LOCALIZED PAIN AT THE CATHETER SITE. SHE DECIDED TO REMOVE THE PUMP CATHETER AROUND 10PM ON (B)(6) 2020 AND PROCEEDED TO THE EMERGENCY DEPARTMENT. [THE PATIENT]...EXPRESSED A DECREASE IN SYMPTOMS UPON REMOVAL BUT THE SYMPTOMS REOCCURRED. UPON ARRIVAL TO THE ED [EMERGENCY DEPARTMENT] AT 11PM HER TEMPERATURE WAS 98.8F. SHE DENIES SYMPTOMS OF TACHYCARDIA OR DIAPHORESIS." PUMP WAS FILLED BY OUTPATIENT PHARMACY AND WAS FILLED BY SYRINGE. FIVE HOURS ELAPSED BETWEEN FILLING THE PUMP AND STARTING THE INFUSION. THE PUMP WAS NOT REFILLED. THE PATIENT WAS GIVEN INSTRUCTIONS ON HOW TO MAINTAIN THE PUMP AND HOW TO REMOVE THE CATHETER WHEN THE PUMP IS EMPTY. THE LAST FACILITY IN-SERVICE WAS ON (B)(6) 2019. THE FLOW RATE WAS NOT CHANGED DURING THERAPY, THE FLOW RATE DIAL KEY WAS REMOVED, AND A WRAP TIE WAS USED TO SECURE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180200 ON-Q PUMP WITH SELECT-A-FLOW ELASTOMERIC - SAF MEB AVANOS MEDICAL - IRVINE CB004 0002976702 10680651134728

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R IBUPROFEN| NORMAL SALINE| OXYCODONE| ROPIVACAINE| TORADOL| TYLENOL