BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS SYR PSD MICROBORE

    MDR report key: 10382786 · Received August 7, 2020

    Report

    Report Number
    9616066-2020-02367
    Event Type
    Malfunction
    Date Received
    August 7, 2020
    Date of Event
    July 15, 2020
    Report Date
    July 17, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403233906
    PMA / PMN Number
    K811885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT TUBING WOULD NOT PRIME.RECEIVED FROM THE CUSTOMER IS ONE USED EXTENSION SETS MODEL 10014914 LOT 20065193. THE SET WAS VISUALLY INSPECTED FOR KINKS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. NO ANOMALIES WERE OBSERVED ON THE SET DURING INITIAL VISUAL INSPECTION.FUNCTIONAL TESTING WAS PERFORMED BY FILLING A LAB SYRINGE WITH BLUE DYE WATER, ATTACHING IT TO THE SETS FEMALE LUER TO BE FLUSHED THROUGH. ATTEMPTING TO PUSH FLUID THROUGH THE SET WAS MET WITH AN OCCLUSION AT THE PRESSURE SENSING DISC AND IT WAS NOT POSSIBLE TO PRIME THE SET. THE OCCLUSION IS SUSPECTED TO BE BETWEEN THE FEMALE LUER AND PRESSURE SENSING DISC SINCE THE PRESSURE SENSING DISC WOULD NOT FILL WITH FLUID.DESTRUCTIVE TESTING WAS ABLE TO DETERMINE THAT THE SOURCE OF THE OCCLUSION IS LOCATED AT THE ENGAGEMENT BETWEEN THE PROXIMAL ENTRANCE OF THE PRESSURE SENSING DISC (P/N 620-00006) AND TUBING (P/N 660136).AN ATTEMPT TO PENETRATE THE EXCESSIVE SOLVENT WAS MADE BY CUTTING THE TUBING AND USING A LAB NEEDLE TO CREATE A CHANNEL THAT WOULD ALLOW FLUID TO FLOW THROUGH. ONCE THE OBSTRUCTION WAS PENETRATED AND A CHANNEL WAS MADE, THE SET ALLOWED FLUID TO FLOW THROUGH SUCCESSFULLY. THIS OBSTRUCTION WAS IDENTIFIED AS THE OCCLUSION CAUSING THE INABILITY TO FLUSH THE EXTENSION SET.A DEVICE HISTORY RECORD FOR MODEL 10014914 WITH LOT NUMBER 20065193 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF 12,003 UNITS WERE BUILT ON 02JUN2020. THERE WERE NO RELATED QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET.THE CUSTOMER¿S REPORT THAT THE TUBING WOULD NOT PRIME WAS CONFIRMED.THE ROOT CAUSE OF THE CUSTOMER¿S REPORT WAS IDENTIFIED AS EXCESSIVE SOLVENT IN THE TUBING NEAR THE ENTRANCE OF THE PRESSURE SENSING DISC ENGAGEMENT WHICH WOULD HAVE OCCURRED DURING THE MANUFACTURING PROCESS. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AS SYR PSD MICROBORE TUBING WOULD NOT PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10014914 BATCH(LOT) NO: 20065193 IT WAS REPORTED THAT TUBING WOULD NOT PRIME. CUSTOMER RESPONSE (ADDITIONAL INFORMATION) (B)(6) 2020: 1. WHAT WERE THE DATES AND TIMES OF THE EVENTS? (B)(6) 20, MOSTLY AT NIGHT. I DO NOT HAVE SPECIFIC DATES/TIMES. 2. WAS THE TUBING SET ATTACHED TO A PATIENT AT THE TIME OF THE EVENT OR OCCURRED DURING PREPARATION/PRIMING? THESE WERE NOT ATTACHED TO A PATIENT, THE EVENT OCCURRED DURING ATTEMPTING TO PRIME. 3. IF PATIENT INVOLVEMENT; WAS THERE ANY EFFECT ON THE PATIENT FROM THE EVENT? N/A 4. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? PLEASE EXPLAIN: DELAY IN GETTING FLUIDS HUNG. 5. WAS THE TUBING STILL COILED WITH TAPE IN PLACE DURING PRIMING/FLUSHING? THE TUBING WAS NOT STILL COILED WITH THE PAPER TAPE DURING PRIMING. 6. HOW FAR IN THE BAG IS THE SPIKE? N/A, IT CONNECTS DIRECTLY TO A SYRINGE AND THE SYRINGE WAS FUNCTIONING APPROPRIATELY. 7. WHAT IV BAG IS IN USE? MANUFACTURER, BRAND & SIZE (50ML, 100ML, ETC.) BD SYRINGES, 5ML-30ML 8. WHAT STEPS DO YOU TAKE TO HELP WHEN YOU DO NOT SEE FLOW? MASSAGE TUBING, SQUEEZE INFUSION BAG, OTHER TECHNIQUE? WHICH ONE OF THESE, IF ANY, HELPS THE FLUID FLOW. WE TRIED DIFFERENT SIZES OF SYRINGES, USING FORCE FROM A SOLID SURFACE AGAINST THE PLUNGER OF THE SYRINGE (BENT THE SYRINGE PLUNGER), STRETCHING AND MASSAGING THE TUBING, MASSAGING THE DISC, AND STILL COULD NOT GET THE FLUID TO PASS THROUGH THE DISC PORTION OF THE PRESSURE SENSING DISC TUBING. 9. ARE THE PRODUCTS INVOLVED IN THE EVENT AVAILABLE FOR INVESTIGATIONAL PURPOSES? YES, THOSE THAT I HAVE I WILL BE SENDING TO YOU. ONE OF THE TUBING SETS WAS PLACED IN THE WRONG PACKAGING, SO I AM NOT SURE OF THE LOT # FOR THAT PARTICULAR PACKAGE. I HAVE ASKED OUR STAFF TO CONTINUE TO TURN IN ANY MORE TUBING THAT IS NOT WORKING I HAVE HAD 3 DIFFERENT NURSES DROP OFF PRESSURE SENSING DISC TUBING IN MY OFFICE THE PAST 2 WEEKS BECAUSE THE TUBING WOULD NOT PRIME. I TRIED MYSELF AND YOU CANNOT PRIME THROUGH THE DISC AT ALL EVEN WITH GREAT FORCE. THEY ARE ALL THE SAME PRODUCT NUMBER, BUT I ONLY HAVE THE LOT NUMBER FOR TWO OF THEM.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS SYR PSD MICROBORE TUBING WOULD NOT PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10014914, BATCH(LOT) NO: 20065193. IT WAS REPORTED THAT TUBING WOULD NOT PRIME. CUSTOMER RESPONSE (ADDITIONAL INFORMATION) 23-JUL-2020: WHAT WERE THE DATES AND TIMES OF THE EVENTS? (B)(6) 2020, MOSTLY AT NIGHT. I DO NOT HAVE SPECIFIC DATES/TIMES. WAS THE TUBING SET ATTACHED TO A PATIENT AT THE TIME OF THE EVENT OR OCCURRED DURING PREPARATION/PRIMING? THESE WERE NOT ATTACHED TO A PATIENT, THE EVENT OCCURRED DURING ATTEMPTING TO PRIME. IF PATIENT INVOLVEMENT; WAS THERE ANY EFFECT ON THE PATIENT FROM THE EVENT? N/A. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? PLEASE EXPLAIN: DELAY IN GETTING FLUIDS HUNG. WAS THE TUBING STILL COILED WITH TAPE IN PLACE DURING PRIMING/FLUSHING? THE TUBING WAS NOT STILL COILED WITH THE PAPER TAPE DURING PRIMING. HOW FAR IN THE BAG IS THE SPIKE? N/A, IT CONNECTS DIRECTLY TO A SYRINGE AND THE SYRINGE WAS FUNCTIONING APPROPRIATELY. WHAT IV BAG IS IN USE? MANUFACTURER, BRAND & SIZE (50ML, 100ML, ETC.) BD SYRINGES, 5ML-30ML WHAT STEPS DO YOU TAKE TO HELP WHEN YOU DO NOT SEE FLOW? MASSAGE TUBING, SQUEEZE INFUSION BAG, OTHER TECHNIQUE? WHICH ONE OF THESE, IF ANY, HELPS THE FLUID FLOW. WE TRIED DIFFERENT SIZES OF SYRINGES, USING FORCE FROM A SOLID SURFACE AGAINST THE PLUNGER OF THE SYRINGE (BENT THE SYRINGE PLUNGER), STRETCHING AND MASSAGING THE TUBING, MASSAGING THE DISC, AND STILL COULD NOT GET THE FLUID TO PASS THROUGH THE DISC PORTION OF THE PRESSURE SENSING DISC TUBING. ARE THE PRODUCTS INVOLVED IN THE EVENT AVAILABLE FOR INVESTIGATIONAL PURPOSES? YES, THOSE THAT I HAVE I WILL BE SENDING TO YOU. ONE OF THE TUBING SETS WAS PLACED IN THE WRONG PACKAGING, SO I AM NOT SURE OF THE LOT # FOR THAT PARTICULAR PACKAGE. I HAVE ASKED OUR STAFF TO CONTINUE TO TURN IN ANY MORE TUBING THAT IS NOT WORKING. I HAVE HAD 3 DIFFERENT NURSES DROP OFF PRESSURE SENSING DISC TUBING IN MY OFFICE THE PAST 2 WEEKS BECAUSE THE TUBING WOULD NOT PRIME. I TRIED MYSELF AND YOU CANNOT PRIME THROUGH THE DISC AT ALL EVEN WITH GREAT FORCE. THEY ARE ALL THE SAME PRODUCT NUMBER, BUT I ONLY HAVE THE LOT NUMBER FOR TWO OF THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845560 AS SYR PSD MICROBORE INTRAVASCULAR ADMINISTRATION SET FPA CAREFUSION 10014914 20065193 10885403233906

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200715| 20200715