BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM V/NV 20D 1CV 2SS DEHP FREE

    MDR report key: 10585882 · Received September 25, 2020

    Report

    Report Number
    9616066-2020-02868
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Date of Event
    August 25, 2020
    Report Date
    September 2, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FPA
    UDI-DI
    07613203021012
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: (B)(6) 2020. INVESTIGATION CONCLUSION: IT WAS REPORTED THAT TUBING CAME APART WHERE THE SOFT TUBING CONNECTS TO THE FIRM TUBING DISTAL TO THE PATIENT. RECEIVED FROM THE CUSTOMER WAS ONE USED PRIMED SET MODEL 2420-0007, LOT UNKNOWN. VISUAL INSPECTION AS RECEIVED CONFIRMED THE SET WAS SEPARATED AT THE PUMPING SEGMENT. THE SEPARATION WAS AT THE ENGAGEMENT BETWEEN THE SILICONE PUMP SEGMENT TUBING P/N (B)(4), AND THE LOWER FITMENT P/N (B)(4).THE RING RETAINER P/N (B)(4), WAS RECEIVED WITH THE SET. NO GAPS ON THE SILICONE SEGMENT SEPARATION OR ANY ANOMALIES WERE NOTED DURING VISUAL INSPECTION. THE EXPECTED RETAINER RING FOR THE LOWER FITMENT AND SILICONE SEGMENT CONNECTION WAS STILL INTACT. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE SET'S SEPARATION AND OBVIOUS LEAKING THAT WOULD OCCUR DUE TO THE SEPARATION. THE SILICONE PUMP TUBING WAS FOUND TO BE WITHIN MEASUREMENT SPECIFICATION. EQUIPMENT USED (INSPECTION AND MEASUREMENT PERFORMED ON (B)(6) 2020: RAM OPTICAL INSTRUMENTATION/EQ08204/CALIBRATION DUE DATE (B)(6) 2021. CALIPERS, EQ02784, CALIBRATION DUE DATE: (B)(6) 20. GAUGE PINS: EQ08349, DUE: (B)(6) 2021. DEVICE HISTORY RECORD COULD NOT BE PERFORMED ON MODEL 2420-0007, BECAUSE THE LOT # FOR THE SUSPECT SET WAS NOT PROVIDED. DEVICE HISTORY RECORD FOR MODEL 2420-0007, LOT 20046307, SHOWS THAT THE SET WAS MANUFACTURED ON (B)(6) 2020, WITH A TOTAL OF (B)(4) UNITS. THERE WERE NO QN¿S (QUALITY NOTIFICATION) ISSUED DURING THE PRODUCTION BUILD OF THIS LOT FOR THE FAILURE MODE REPORTED. ALTHOUGH THE ROOT CAUSE OF THE SEPARATION COULD NOT BE DEFINITIVELY DETERMINED, AT SOME POINT THE SET MAY HAVE BEEN PULLED OR STRETCHED BEYOND THE RETENTION SPECIFICATION BETWEEN THE SILICONE SEGMENT AND THE SET¿S UPPER FITMENT DURING USE OR SET LOADING. TJ MANUFACTURING HAS BEEN PREVIOUSLY NOTIFIED OF THIS ISSUE. A SYSTEMIC FAILURE INVESTIGATION FOR PUMP SEGMENT ISSUES WILL BE DOCUMENTED BY DIR #( B)(4), H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO GEM V/NV 20D 1CV 2SS DEHP FREE EXPERIENCED LEAKAGE AND COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT HAPPENED ON (B)(6) 2020. STUDENT FOR ANESTHESIA WAS PUSHING IV MEDS AND 10 ML SYRINGE DURING EGD/COLONOSCOPY CASE. THE TUBING CAME APART WHERE THE SOFT TUBING CONNECTS TO THE FIRM TUBING DISTAL TO THE PATIENT. SINCE THE IV WAS STARTED IN PREOP, COULD NOT RECOVER LOT# EXACTLY. ONES ON SUPPLY CART (B)(4). NEW TUBING HUNG AND PROCEDURE CONTINUED.

    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 20046307, MEDICAL DEVICE EXPIRATION DATE: 04/17/2023, DEVICE MANUFACTURE DATE: 04/17/2020.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO GEM V/NV 20D 1CV 2SS DEHP FREE EXPERIENCED LEAKAGE AND COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT HAPPENED ON (B)(6) 2020. STUDENT FOR ANESTHESIA WAS PUSHING IV MEDS AND 10 ML SYRINGE DURING EGD/COLONOSCOPY CASE. THE TUBING CAME APART WHERE THE SOFT TUBING CONNECTS TO THE FIRM TUBING DISTAL TO THE PATIENT. SINCE THE IV WAS STARTED IN PREOP, COULD NOT RECOVER LOT# EXACTLY. ONES ON SUPPLY CART 20046307. NEW TUBING HUNG AND PROCEDURE CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049231 GEM V/NV 20D 1CV 2SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. SEE H10 07613203021012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other