BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLUMAT MC AGILIA

    MDR report key: 9565761 · Received January 8, 2020

    Report

    Report Number
    3000240707-2020-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2020
    Date of Event
    December 5, 2019
    Report Date
    December 10, 2019
    Manufacturer
    FRESENIUS VIAL S.A.S.
    Product Code
    FRN
    PMA / PMN Number
    K121613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    UNDERDOSE; PT IDENTIFIER FEMALE, LR, (B)(6) 1944 PT HAD 4 IV MEDS DURING 24 HOUR PERIOD- 2 DRUGS HAD ISSUE OF NOT COMPLETELY INFUSING AS PROGRAMMED & 2 DRUGS DID NOT HAVE THE ISSUE. SAME PRIMARY (PR 42-11) AND SECONDARY (SL00-0) USED FOR 24 H PERIOD. AGILIA VP MC WIFI, SN (B)(6) DRUG #1 SECONDARY INFUSION OF PIP TAZ, VTBI 65 ML, IN 30 MIN. (NOT FRESENIUS KABI DRUG) ISSUE: 25 ML OF DRUG REMAINING IN BAG AT 30 MIN, AUTOMATIC RETURN TO PRIMARY. ISSUE NOTED AT 30 MIN TIME WHEN DRUG SHOULD HAVE BEEN INFUSED. AT THIS TIME, NURSE REPROGRAMED THE REMAINING 25ML VTBI AND DELIVERED REST OF DRUG, NO ALARMS NOTED DURING INFUSION. DELIVERED THE REST OF DRUG WITH NO ISSUE. PT CONNECTED, NO ADVERSE EVENT, NO PT DETERIORATION DRUG # 2 POTASSIUM PRE-FILLED BAG, VTBI 100ML, IN 1 H (NOT FRESENIUS KABI DRUG) PICTURE AVAILABLE FOR IV SET UP ON PUMP. ISSUE NOTED AT 30 MIN TIME WHEN DRUG SHOULD HAVE BEEN INFUSED. AT THIS TIME, NURSE REPROGRAMED THE REMAINING 30ML VTBI AND DELIVERED REST OF DRUG. NURSE DID NOT NOTE ALARMS DURING INFUSION. DELIVERED THE REST OF DRUG WITH NO ISSUE PT CONNECTED, NO ADVERSE EVENT, NO PT DETERIORATION NO ISSUE REPORTED PRIMING THE IV SETS. DEVICE HISTORY RECORD WAS REVIEWED, NO EVENT LINKED TO THE REPORTED ISSUE WAS OBSERVED. DEVICE LOG WAS NOT PROVIDED SO NO REVIEW COULD BE PERFORMED. HOWEVER, THE REPORTED EVENT IS A KNOWN ISSUE AND HISTORY LOG WOULD NOT HAVE BEEN RELEVANT. DEVICE WAS NOT ASKED FOR INVESTIGATION AS THE REPORTED EVENT WAS LINKED TO A SIMILAR ISSUE THAT HAS ALREADY BEEN INVESTIGATED. THE REPORTED EVENT COULD NOT BE REPRODUCED. NO TECHNICAL NOR FUNCTIONNAL DEFECT BEING IDENTIFIED ON THE RETURNED DEVICE DURING CONTROL TESTING, THE COMPLIANCE WITH IFU FOR USE WITH SECONDARY INFUSION WAS CHECKED WITH THE CUSTOMER. IT APPEARED THAT THE HANGER USED FOR SECONDARY INFUSION IV SET WAS ONLY 8 INCHES LONG (20CM) WHEN THE IFU RECOMMENDATION IS THAT THE DISTANCE BETWEEN THE PRIMARY AND SECONDARY BAG SHOULD BE 12 INCHES (30CM). THEREFORE THE CONDITION OF USE WERE NOT WITHIN RECOMMENDATION SPECIFIED IN THE IFU. USING TWO HANGERS WOULD ALLOW TO ACHIEVE REQUIREMENTS. THIS WAS SUGGESTED TO THE CUSTOMER WHO APPLIED THIS WORKAROUND AND CONFIRMED THAT EVER SINCE USING TWO HANGERS TO LOWER THE PRIMARY BAG, THEY DID NOT GET ANY ISSUE IN DELIVERING THE SECONDARY MEDICATION.

    Description of Event or Problem · 1

    UNDERDOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27367 VOLUMAT MC AGILIA INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1