BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM V/NV NTG 20DP 20PK

    MDR report key: 10818020 · Received November 10, 2020

    Report

    Report Number
    2243072-2020-01801
    Event Type
    Malfunction
    Date Received
    November 10, 2020
    Date of Event
    October 13, 2020
    Report Date
    December 3, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K931173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED: A.2. AGE AT TIME OF EVENT: 7 A.2. AGE UNIT: DAYS A.2. DATE OF BIRTH: (B)(6) 2020 A.3. SEX: MALE B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE GEM V/NV NTG 20DP 20PK EXPERIENCED AIR BUBBLES/AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 2260-0500 BATCH NO: UNKNOWN AIR IN LINE NOTED FROM SECONDARY PORT OF DOUBLE LUMEN UVC. TPN INFUSING AT 3ML/HOUR. FLUIDS HUNG 23.5 HOURS EARLIER. NURSE REMOVED AIR FROM LINE. PUMP POSITIONED HIGHER THAN PATIENT-DISCUSSED PROPER PLACEMENT OF PUMP AND MOVED TO LEVEL OF PATIENT. PUMP, TUBING, AND CHANNEL SENT TO BIOMED. D.1. MEDICAL DEVICE BRAND NAME: GEM V/NV NTG 20DP 20PK D.1. COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET D.2. MEDICAL DEVICE MANUFACTURER: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. D.2. MEDICAL DEVICE TYPE: FPA. D.4. MEDICAL DEVICE CATALOG #: 2260-0500 D.4. MEDICAL DEVICE LOT #: UNKNOWN. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D.10. DEVICE AVAILABLE FOR EVAL.?: YES. D.10. RETURNED TO MANUFACTURER ON: 2020-11-09. G.1. MANUFACTURING LOCATION: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. G.5. PMA/510(K)#: K931173. H.3. DEVICE AVAILABLE FOR EVAL.?: YES. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE SAMPLE WAS RETURNED FOR INVESTIGATION. LINE BROKE DURING ASPIRATION DURING DECON. AN INVESTIGATION COULD NOT BE CONDUCTED. THE ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE ISSUE COULD NOT BE REPLICATED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL: 2260-0050 BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GEM V/NV NTG 20DP 20PK EXPERIENCED AIR BUBBLES/AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 2260-0500 BATCH NO: UNKNOWN AIR IN LINE NOTED FROM SECONDARY PORT OF DOUBLE LUMEN UVC. TPN INFUSING AT 3ML/HOUR. FLUIDS HUNG 23.5 HOURS EARLIER. NURSE REMOVED AIR FROM LINE. PUMP POSITIONED HIGHER THAN PATIENT-DISCUSSED PROPER PLACEMENT OF PUMP AND MOVED TO LEVEL OF PATIENT. PUMP, TUBING, AND CHANNEL SENT TO BIOMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GEM V/NV NTG 20DP 20PK EXPERIENCED AIR BUBBLES / AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 2260-0500, BATCH NO: UNKNOWN. AIR IN LINE NOTED FROM SECONDARY PORT OF DOUBLE LUMEN UVC. TPN INFUSING AT 3ML/HOUR. FLUIDS HUNG 23.5 HOURS EARLIER. NURSE REMOVED AIR FROM LINE. PUMP POSITIONED HIGHER THAN PATIENT-DISCUSSED PROPER PLACEMENT OF PUMP AND MOVED TO LEVEL OF PATIENT. PUMP, TUBING, AND CHANNEL SENT TO BIOMED.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED INTERVASCULAR ADMINISTRATION SET EXPERIENCED AIR BUBBLES/AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN. AIR IN LINE NOTED FROM SECONDARY PORT OF DOUBLE LUMEN UVC. TPN INFUSING AT 3ML/HOUR. FLUIDS HUNG 23.5 HOURS EARLIER. NURSE REMOVED AIR FROM LINE. PUMP POSITIONED HIGHER THAN PATIENT-DISCUSSED PROPER PLACEMENT OF PUMP AND MOVED TO LEVEL OF PATIENT. PUMP, TUBING, AND CHANNEL SENT TO BIOMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1282037 GEM V/NV NTG 20DP 20PK INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA