BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD GEM 20D V/NV NTG .2MF 1SS DEHP FREE

    MDR report key: 12907931 · Received December 1, 2021

    Report

    Report Number
    9616066-2021-52508
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    November 2, 2021
    Report Date
    November 3, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    37613203015814
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF COMPONENT DAMAGE - LEAK COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW FOR MODEL 1001045, LOT NUMBER 20095932 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 07SEP2020. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. NO PRODUCT WILL BE RETURNED PER CUSTOMER. NO INVESTIGATION WAS PERFORMED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF COMPONENT DAMAGE - LEAK COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW FOR MODEL 1001045, LOT NUMBER 20095932 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 07SEP2020. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. NO PRODUCT WILL BE RETURNED PER CUSTOMER. NO INVESTIGATION WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD GEM 20D V/NV NTG .2MF 1SS DEHP FREE EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PT AND PICC CHECKED AT 2200, UPON CHECKING PT AT 2300 NOTED TPN LINE TO BE BROKEN AND DRIPPING ONTO FLOOR. CHECKED PICC AND PICC INSITU, AND IV TUBING LINE HAD SNAPPED AT TPN FILTER. LIPIDS WERE Y'D INTO LINE BELOW THE FILTER THEREFORE LIPIDS WERE STILL INFUSING INTO LUMEN. LINE CLAMPED AND PUMP STOPPED. ANOTHER RN IN TO ASSIST AND PRIMED D5.9NS LINE, TPN LINES REMOVED AND LINES CLEANSED AS PER CVL PROTOCOL. NEW LINE WITH D5.9NS CONNECTED AND STARTED. RED JR CALLED TO NOTIFY OF EVENT. TPN PUT ON HOLD FOR NIGHT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD GEM 20D V/NV NTG .2MF 1SS DEHP FREE EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PT AND PICC CHECKED AT 2200, UPON CHECKING PT AT 2300 NOTED TPN LINE TO BE BROKEN AND DRIPPING ONTO FLOOR. CHECKED PICC AND PICC INSITU, AND IV TUBING LINE HAD SNAPPED AT TPN FILTER. LIPIDS WERE Y'D INTO LINE BELOW THE FILTER THEREFORE LIPIDS WERE STILL INFUSING INTO LUMEN. LINE CLAMPED AND PUMP STOPPED. ANOTHER RN IN TO ASSIST AND PRIMED D5.9NS LINE, TPN LINES REMOVED AND LINES CLEANSED AS PER CVL PROTOCOL. NEW LINE WITH D5.9NS CONNECTED AND STARTED. RED JR CALLED TO NOTIFY OF EVENT. TPN PUT ON HOLD FOR NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1811285 BD GEM 20D V/NV NTG .2MF 1SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 10010454 20095932 37613203015814

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown