BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10463639 · Received August 27, 2020

    Report

    Report Number
    9616066-2020-02661
    Event Type
    Malfunction
    Date Received
    August 27, 2020
    Date of Event
    July 28, 2020
    Report Date
    August 5, 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
    CA
    Reporter Occupation
    NURSE

    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: 20200728. INVESTIGATION CONCLUSION. IT WAS REPORTED THAT TUBING SEPARATED AT CONNECTION POINT BELOW THE BLUE SLIDE CLAMP, CAUSING DRUG SPILLS. RECEIVED FROM THE CUSTOMER IS ONE PRIMARY SET MODEL 2420-0007 LOT UNKNOWN. THE SET WAS VISUALLY INSPECTED FOR KINKS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. VISUAL INSPECTION OBSERVED A SEPARATION AT THE ENGAGEMENT BETWEEN THE LOWER FITMENT (P/N TC10006063) AND TUBING (P/N TC10011704). CLOSER INSPECTION OF THE SEPARATIONS UNDER A LAB MICROSCOPE OBSERVED THAT THE TUBING HAD AN INSUFFICIENT SOLVENT APPLIED AT THE ENGAGEMENT DURING MANUFACTURING PROCESS. NO OTHER ANOMALIES WERE OBSERVED WITH THE SET. FUNCTIONAL TESTING COULD NOT BE PERFORMED AS A LEAK WOULD OCCUR. A DIMENSIONAL ANALYSIS WAS PERFORMED ON EACH SEPARATED TUBING (P/N TC10013433). SMALL PORTIONS OF THE TUBING WERE CUT INTO THREE SECTIONS NEAREST TO THE SMARTSITE¿S INLET PORT AND MEASURED FOR ANALYSIS. THE OUTER DIAMETER OF THE TUBING WAS MEASURED AND OBSERVED TO BE WITHIN SPECIFICATIONS OF "0.164 +/-0.003" INCHES. EQUIPMENT USED (MEASUREMENT AND TESTING PERFORMED ON (B)(6) 2020). - OPTICAL RAM-CNC, EQ08204, CALIBRATION DUE DATE: 5-FEB-21. DEVICE HISTORY RECORD FOR MODEL 2420-0007 COULD NOT BE PERFORMED DUE TO NO LOT NUMBER BEING PROVIDED BY CUSTOMER. THE CUSTOMER'S REPORT OF A SEPARATION AND LEAK WAS CONFIRMED TO BE A SEPARATION AT THE ENGAGEMENT BETWEEN THE TUBING AND LOWER FITMENT. THE ROOT CAUSE OF THE SEPARATION WAS IDENTIFIED AS A MANUFACTURING ISSUE FOR INSUFFICIENT SOLVENT BEING APPLIED AT THE ENGAGEMENT OF THE TUBING DUE TO EQUIPMENT AND/OR OPERATOR ERROR. BD/NOGALES MANUFACTURING FACILITY IS AWARE OF INSUFFICIENT SOLVENT ON CRITICAL JOINTS. CORRECTIVE ACTIONS (TRACKWISE CAPA PR 1027651) TO ADDRESS POTENTIAL ROOT CAUSES AND AN EFFECTIVENESS CHECK PLAN FOR REDUCTION OF ISSUE HAVE BEEN INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 7 GEM V/NV 20D 1CV 2SS DEHP FREE EXPERIENCED COMPONENT SEPARATION, LEAKAGE, AND AIR BUBBLES/AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD MULTIPLE OCCASIONS WHERE THE LINE HAS SEPARATED AT THE CONNECTION POINT BELOW THE BLUE SLIDE CLAMP. THIS HAS RESULTED IN LINES WITH AIR BUBBLES AND ALSO DRUG SPILLS (THANKFULLY NOT CYTOTOXIC) ADDITIONAL INFORMATION (CUSTOMER RESPONSE) 17-AUG-2020: WAS THE TUBING SET ATTACHED TO A PATIENT AT THE TIME OF THE EVENT OR OCCURRED DURING PREPARATION/SETUP OR WHEN TAKEN OUT OF PACKAGE? IN THE CASE OF THE ISSUE WHERE THE DRUG WAS SPILLED THE LINE WAS CONNECTED TO THE PATIENT ¿ ALL OTHER OCCURRENCES WERE PRIOR TO CONNECTING TO PATIENT. 2. IF PATIENT INVOLVEMENT; WAS THERE ANY EFFECT ON THE PATIENT FROM THE EVENT? NONE KNOWN. 3. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? PLEASE EXPLAIN: DELAY DUE TO NEED TO RE-PRIME AND HANG REMAINING DRUG ¿ MAYBE 10 MINUTE DELAY. 4. EXPOSURE TO BLOOD/BODILY FLUID/IV SOLUTION? IF YES, PLEASE EXPLAIN: NO. 5. WHAT WAS THE TUBING SET MATERIAL AND/OR LOT NUMBER THAT WAS IN USE AT THE TIME OF THE EVENT? I DON¿T KNOW UNFORTUNATELY. PACKAGING HAD ALL BEEN THROWN AWAY WHEN THE ISSUE WAS DISCOVERED. 6. ARE STAFF AWARE OF CORRECT SET LOADING/UNLOADING METHOD? AWARE NOT TO PULL/STRETCH SET? YES.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 7 GEM V/NV 20D 1CV 2SS DEHP FREE EXPERIENCED COMPONENT SEPARATION, LEAKAGE, AND AIR BUBBLES/AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD MULTIPLE OCCASIONS WHERE THE LINE HAS SEPARATED AT THE CONNECTION POINT BELOW THE BLUE SLIDE CLAMP. THIS HAS RESULTED IN LINES WITH AIR BUBBLES AND ALSO DRUG SPILLS (THANKFULLY NOT CYTOTOXIC). ADDITIONAL INFORMATION (CUSTOMER RESPONSE) 17-AUG-2020: WAS THE TUBING SET ATTACHED TO A PATIENT AT THE TIME OF THE EVENT OR OCCURRED DURING PREPARATION/SETUP OR WHEN TAKEN OUT OF PACKAGE? IN THE CASE OF THE ISSUE WHERE THE DRUG WAS SPILLED THE LINE WAS CONNECTED TO THE PATIENT ¿ ALL OTHER OCCURRENCES WERE PRIOR TO CONNECTING TO PATIENT. IF PATIENT INVOLVEMENT; WAS THERE ANY EFFECT ON THE PATIENT FROM THE EVENT? NONE KNOWN. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? PLEASE EXPLAIN: DELAY DUE TO NEED TO RE-PRIME AND HANG REMAINING DRUG ¿ MAYBE 10 MINUTE DELAY. EXPOSURE TO BLOOD/BODILY FLUID/IV SOLUTION? IF YES, PLEASE EXPLAIN: NO. WHAT WAS THE TUBING SET MATERIAL AND/OR LOT NUMBER THAT WAS IN USE AT THE TIME OF THE EVENT? I DON¿T KNOW UNFORTUNATELY. PACKAGING HAD ALL BEEN THROWN AWAY WHEN THE ISSUE WAS DISCOVERED. ARE STAFF AWARE OF CORRECT SET LOADING/UNLOADING METHOD? AWARE NOT TO PULL/STRETCH SET? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925946 GEM V/NV 20D 1CV 2SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. UNKNOWN 07613203021012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200728.| 20200728.| 20200728