BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEC SET NO PORTS W/HANGER DEHP FREE

    MDR report key: 10428347 · Received August 19, 2020

    Report

    Report Number
    9616066-2020-02519
    Event Type
    Malfunction
    Date Received
    August 19, 2020
    Date of Event
    July 24, 2020
    Report Date
    July 27, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FPA
    UDI-DI
    10885403234743
    PMA / PMN Number
    K790582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES. D.10 RETURNED TO MANUFACTURER ON: 08/14/2020. INVESTIGATION CONCLUSION THE CUSTOMER REPORTED THAT MEDICATION FLOWED FROM THE SECONDARY TUBING INTO THE PRIMARY TUBING. RECEIVED WERE THE FOLLOWING USED SAMPLES- 1)PRIMARY SET MODEL 2420-0007 LOT REPORTED AS 20046586, 2)SECONDARY SET MODEL 11448964 LOT REPORTED AS 20043100, 3)(BAG 1) FULL NON-BD (BAXTER) 250ML INFUSION BAG 5% DEXTROSE INJECTION USP LOT WOE14B0 EXP AUG21, AND 4)(BAG 2) EMPTY NON-BD (BAXTER) 250ML INFUSION BAG 5% DEXTROSE INJECTION USP LOT WOD23C1 EXP JUL21. THE SAMPLES WERE RECEIVED ATTACHED TO EACH OTHER: BAG 1 TO PRIMARY SET. BAG 2 TO SECONDARY SET. SECONDARY SET'S MALE LUER TO PRIMARY SET'S TOP SMARTSITE PORT. THE AS-RECEIVED SAMPLE WAS VISUALLY INSPECTED FOR KINKS, HOLES/TEARS IN THE TUBING, OR DAMAGES TO THE COMPONENTS. NO OBVIOUS DAMAGE OR ISSUE WAS OBSERVED. FUNCTIONAL TESTING WAS PERFORMED BY REPRIMING THE PRIMARY SET SAMPLE FROM ITS ATTACHED INFUSION BAG. BAG 2 (ATTACHED TO THE SECONDARY SET) WAS REPLACED WITH A LAB INFUSION BAG FILLED WITH BLUE DYED FLUID AND THE SECONDARY SET WAS REPRIMED. THE SETS WERE HUNG IN A SECONDARY INFUSION CONFIGURATION. THE PRIMARY SET'S ROLLER CLAMP WAS SLOWLY OPENED UNTIL FLUID DROPS WERE OBSERVED ONLY WITHIN THE SECONDARY SET'S DRIP CHAMBER. IT WAS OBSERVED THAT THE BLUE DYE FLUID IMMEDIATELY TRAVELLED UP THE TUBING DIRECTLY BELOW THE PRIMARY SET'S CHECK VALVE P/N 630-00327 COMPONENT. IT WAS OBSERVED THERE WAS BLUE DYE FLUID WITHIN THE BOTTOM OF THE CHECK VALVE INDICATING A FAULTY CHECK VALVE. NO BLUE DYE FLUID WAS OBSERVED PAST THE TOP OF THE CHECK VALVE. FUNCTIONAL TESTING, WATER TEST, AND DIMENSIONAL ANALYSIS OF PREVIOUS COMPLAINTS WITH THE FAILURE MODE OF ¿BACKFLOW/FAILED CHECK VALVE¿ WERE PERFORMED (BY THE CHECK VALVE SUPPLIER) TO EVALUATE CHECK VALVE FUNCTIONALITY AND COMPONENT DIMENSION SPECIFICATIONS. THE SAMPLE IS ALSO SUBJECTED TO RE-INSPECTION BY THE AUTOMATED INSPECTION SYSTEM. PREVIOUS TESTING HAS SHOWN THAT A PARTICULATE, OFF-CENTER MEMBRANE OR DISC PINCH CAN CAUSE A VALVE TO REMAIN OPEN ALLOWING BACKFLOW TO OCCUR. BD TJ MANUFACTURING SUPPLIER QUALITY WAS INFORMED. A SUPPLIER NOTIFICATION MEMO WAS PROVIDED AND THE SAMPLE WAS SENT TO SUPPLIER. THE DEVICE HISTORY RECORD FOR SET MODEL 2420-0007 LOT 20046586 SHOWS THE SET WAS MANUFACTURED ON 22APR2020 WITH A TOTAL OF 34,563 UNITS BUILT. THERE WERE NO QUALITY NOTIFICATIONS ISSUED DURING THE PRODUCTION BUILD OF THIS SET. THE CUSTOMER¿S REPORT THAT FLUID FLOWED FROM THE SECONDARY TUBING INTO THE PRIMARY TUBING WAS CONFIRMED. PREVIOUSLY INVESTIGATED COMPLAINTS FOR THE SAME FAILURE MODE DETERMINED THAT THE BACKFLOW CAN BE CAUSED BY A PARTICULATE, OFF-CENTER MEMBRANE OR DISK/DIAPHRAGM PINCH THAT CAN CAUSE THE VALVE TO REMAIN OPEN ALLOWING BACKFLOW TO OCCUR. WHILE OFF-CENTER MEMBRANE AND DISK/DIAPHRAGM ARE SUPPLIER ISSUES, THE PRESENCE OF PARTICULATE IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SEC SET NO PORTS W/HANGER DEHP FREE EXPERIENCED A CHECK VALVE MALFUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MEDICATION WAS HUNG ON THE SECONDARY IV SET AND NOTED FOUND TO FLOW INTO THE PRIMARY TUBING. ADDITIONAL INFORMATION FROM CUSTOMER: 1. DID THE EVENT ONLY OCCUR ON (B)(6) 2020 OR DID IT OCCUR ON 4 SEPARATE DAYS (AS REPORTED IN THE PRODUCT COMPLAINT FORM)? THE EVENT OCCURRED ON JULY 24TH. THE PRODUCT WAS IN USE FOR 4 DAYS AS IS INDICATED IN THE PRODUCT COMPLAINT FORM. 2. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? PLEASE EXPLAIN: DELAY, NEW DRUG NEEDED TO BE MADE. 3. EXPOSURE TO BLOOD/BODILY FLUID/IV SOLUTION? IF YES, PLEASE EXPLAIN -NO 4. WHAT WAS THE PRIMARY MEDICATION/FLUID THAT WAS IN USE AT THE TIME OF THE EVENT? D5W 5. WHAT WAS THE SECONDARY MEDICATION/FLUID THAT WAS INFUSING AT THE TIME OF THE EVENT? AMPHOTERICIN B 6. WAS THE PROPER HEAD-HEIGHT SET-UP USED FOR THE PRIMARY AND SECONDARY INFUSIONS? YES 7. ARE YOU ABLE TO PROVIDE PATIENT DEMOGRAPHICS (EX. DOB, H&W, AGE, GENDER, OTHER RELEVANT MEDICAL INFORMATION)? NO PATIENT INFORMATION WILL BE PROVIDED AS PER OUR INSTITUTIONAL PRIVACY GUIDELINES.

    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 SEC SET NO PORTS W/HANGER DEHP FREE EXPERIENCED A CHECK VALVE MALFUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MEDICATION WAS HUNG ON THE SECONDARY IV SET AND NOTED FOUND TO FLOW INTO THE PRIMARY TUBING. ADDITIONAL INFORMATION FROM CUSTOMER: DID THE EVENT ONLY OCCUR ON (B)(6) 2020 OR DID IT OCCUR ON 4 SEPARATE DAYS (AS REPORTED IN THE PRODUCT COMPLAINT FORM)? THE EVENT OCCURRED ON (B)(6). THE PRODUCT WAS IN USE FOR 4 DAYS AS IS INDICATED IN THE PRODUCT COMPLAINT FORM. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? PLEASE EXPLAIN: DELAY, NEW DRUG NEEDED TO BE MADE. EXPOSURE TO BLOOD/BODILY FLUID/IV SOLUTION? IF YES, PLEASE EXPLAIN -NO. WHAT WAS THE PRIMARY MEDICATION/FLUID THAT WAS IN USE AT THE TIME OF THE EVENT? D5W. WHAT WAS THE SECONDARY MEDICATION/FLUID THAT WAS INFUSING AT THE TIME OF THE EVENT? AMPHOTERICIN B. WAS THE PROPER HEAD-HEIGHT SET-UP USED FOR THE PRIMARY AND SECONDARY INFUSIONS? YES. ARE YOU ABLE TO PROVIDE PATIENT DEMOGRAPHICS (EX. DOB, H&W, AGE, GENDER, OTHER RELEVANT MEDICAL INFORMATION)? NO PATIENT INFORMATION WILL BE PROVIDED AS PER OUR INSTITUTIONAL PRIVACY GUIDELINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889096 SEC SET NO PORTS W/HANGER DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. 20043100 10885403234743

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 8100,2420-0007,8015, (B)(4)| 8100,2420-0007,8015, (B)(4)