BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q* PUMP WITH SELECT-A-FLOW*

    MDR report key: 7381752 · Received March 29, 2018

    Report

    Report Number
    2026095-2018-00040
    Event Type
    Malfunction
    Date Received
    March 29, 2018
    Report Date
    February 28, 2018
    Manufacturer
    HALYARD - IRVINE
    Product Code
    MEB
    UDI-DI
    30680651136856
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 23MAR2018 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 HALYARD HEALTH 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 HALYARD HEALTH. HALYARD HEALTH 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    FILL VOLUME: 400 ML . FLOW RATE: 6 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: PORT. HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT PATIENTS. THIS IS THE SEVENTH OF EIGHT REPORTS. PATIENT A - 48 HRS. 2026095-2018-00034 ONLY, PATIENT B - 48 HRS. 2026095-2018-00035 ONLY, PATIENT C - 52.5 HRS. 2026095-2018-00036 ONLY, PATIENT D - 50.5 HRS. 2026095-2018-00037 ONLY, PATIENT E - 50.5 HRS. 2026095-2018-00038 ONLY, PATIENT F - 51.5 HRS. 2026095-2018-00039 ONLY, PATIENT G - LESS THAN 50 HRS. (PATIENT COULD NOT GIVE ME THE EXACT TIME CATHETER WAS REMOVED, BUT WAS DEFINITELY LESS THAN 50 HRS. ADD THIS TO 2026095-2018-00040 ONLY, PATIENT H - PATIENT COULD NOT TELL THE DAY OR TIME CATHETER WAS REMOVED BUT BASED ON OUR DISCUSSIONS AND THE SIZE OF THE PAIN BALL WHEN HE LEFT THE HOSPITAL, I SUSPECT IN THE RANGE OF 50 HRS. ADD THIS TO 2026095-2018-00041 ONLY. THE DOCTOR STATED ¿THE PUMPS ARE INFUSING INCORRECTLY BECAUSE AT 6 ML/HR I WOULD EXPECT SOME OF THEM TO BE CLOSER TO 67 HRS. MOST IF NOT ALL ARE INFUSING FASTER THAN THIS RATE. ADDITIONAL INFORMATION WAS RECEIVED 01-MAR-2018 FROM THE DOCTOR THAT STATED THE INCIDENT DATES WERE (B)(6) (PLACEMENT DATES OF CATHETERS). THERE WERE NO PATIENT CONSEQUENCES. THE PATIENTS WERE INSTRUCTED TO CARRY THE PUMPS IN THE BLACK BAG SUPPLIED AROUND THEIR NECK MUCH LIKE A PURSE AND ALSO CARRIED OVER THEIR CLOTHING. THE KEYS ARE NOT REMOVED. WE DO NOT TIE WRAP. THE RATE OF 6 ML/HR WAS NOT CHANGED ON ANY OF THESE PUMPS. ALL OF THE PUMPS ARE FILLED BY THE PHARMACY WITH 400 ML OF 0.2% ROPIVACAINE WITH A REPEATER PUMP. ONCE FILLED, THE PUMPS ARE PLACED IN THE REFRIGERATOR AND REMOVED THE NIGHT BEFORE IT IS TO BE USED. THE PUMP(S) CAN BE FILLED UP TO A WEEK BEFORE IT IS NEEDED. NO ADDITIONAL INFORMATION WAS PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224032 ON-Q* PUMP WITH SELECT-A-FLOW* ELASTOMERIC ¿ SAF MEB HALYARD - IRVINE P400X2-14 UNKNOWN 30680651136856

    Patients

    Seq Age Sex Outcome Treatment
    1