BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 8445468 · Received March 22, 2019

    Report

    Report Number
    9610825-2019-00069
    Event Type
    Malfunction
    Date Received
    March 22, 2019
    Date of Event
    February 15, 2019
    Report Date
    April 25, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEA
    PMA / PMN Number
    K092313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018. B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). FAILURE ANALYSIS AND INVESTIGATION RESULTS DID NOT CONFIRM THE REPORTED ISSUE. UPON RECEIPT THE ACTUAL PUMP INVOLVED WAS VISUALLY INSPECTED, AND THE INFUSION DATA LOGS WERE DOWNLOADED FROM THE PUMP. THE LOG REVIEW SHOWS AN INFUSION WAS STARTED ON (B)(6) 2019 AT 1:41PM WITH A RATE OF 1.74ML/HR AND A TOTAL VOLUME OF 41.55ML WITH TERUMO 50ML SYRINGE (DL: CYTARABIN). ON (B)(6) 2019 AT 12:33PM SYRINGE NEAR EMPTY ALARMED AND AT 12:38PM THE INFUSION STOPPED WITH A VOLUME INFUSED TO 39.96ML. THE TOTAL INFUSION TIME WAS 22 HOURS AND 57 MIN. AT THE RATE THAT WAS PROGRAMMED, THE EXPECTED VOLUME INFUSED WOULD BE 39.93ML. THE 39.96MLS THAT WERE INFUSED ARE WITHIN THE DEVICE SPECIFICATION. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER. BASED ON THE RESULTS OF THE INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY: OVER INFUSION OF CYTARABINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237721 PERFUSOR® PUMP, INFUSION, PCA MEA B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR