BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM 20DP V/NV 1.2MF DEHP FREE

    MDR report key: 10411519 · Received August 14, 2020

    Report

    Report Number
    9616066-2020-02485
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    July 9, 2020
    Report Date
    July 24, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FPA
    UDI-DI
    10885403274039
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT OF COLLAPSED TUBING WAS RECEIVED FROM THE CUSTOMER. NO PRODUCT WAS RETURNED SO THE COMPLAINT COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2202-0007 LOT NUMBER 20026414 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) IN 1 LOT NUMBER WAS BUILT ON 18FEB2020. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GEM 20DP V/NV 1.2MF DEHP FREE EXPERIENCED DEFECTIVE/DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIPTION SUMMARY: TUBING BROKEN AT TOP OF BLUE PORT THAT GOES INTO THE PUMP. CUSTOMER'S PROBLEM REPORT # (B)(4). EVENT DATE: (B)(6) 2020. WAS THERE AN INJURY: NO. WAS THERE A DEATH: NO. CITY: (B)(6). STATE/PROVINCE: (B)(6). POSTAL CODE: (B)(6) . COUNTRY: UNITED STATES ADDRESS 1: (B)(6). PRODUCT: 2202-0007~TPMECC. PRODUCT EVENT TYPE: DISTRIBUTOR COMPLAINT. PRODUCT NAME: GEM 20DP V/BV 1.2MF DEHP FREE. PRODUCT TYPE: MEDICAL DEVICE. PRODUCT CATEGORY: DURABLE MEDICAL EQUIPMENT. PRODUCT GROUP: DISTRIBUTED. SUPPLIER NAME: CAREFUSION 2200 INC. MANUFACTURING SITE: DIST. COMPLAINT QUANTITY: 1.00. MFG. SKU NUMBER: 2202-0007. LOT # 1020026414. PRODUCT MALFUNCTION/FAILURE MODE AS REPORTED: TUBING COLLAPSE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GEM 20DP V/NV 1.2MF DEHP FREE EXPERIENCED DEFECTIVE/DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIPTION SUMMARY: TUBING BROKEN AT TOP OF BLUE PORT THAT GOES INTO THE PUMP. CUSTOMER'S PROBLEM REPORT # (B)(6). EVENT DATE: (B)(6) 2020. WAS THERE AN INJURY: NO. WAS THERE A DEATH: NO. (B)(6). PRODUCT: 2202-0007~TPMECC. PRODUCT EVENT TYPE: DISTRIBUTOR COMPLAINT. PRODUCT NAME: GEM 20DP V/BV 1.2MF DEHP FREE. PRODUCT TYPE: MEDICAL DEVICE. PRODUCT CATEGORY: DURABLE MEDICAL EQUIPMENT. PRODUCT GROUP: DISTRIBUTED. SUPPLIER NAME: CAREFUSION 2200 INC. MANUFACTURING SITE: DIST. COMPLAINT QUANTITY: 1.00. MFG. SKU NUMBER: 2202-0007. LOT # 1020026414. PRODUCT MALFUNCTION/FAILURE MODE AS REPORTED: TUBING COLLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873375 GEM 20DP V/NV 1.2MF DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. 20026414 10885403274039

    Patients

    Seq Age Sex Outcome Treatment
    0 Other 20200709
    1 Other| O 20200709| 20200709