BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS LVP 20D DEHP 2SS CV

    MDR report key: 10318945 · Received July 24, 2020

    Report

    Report Number
    9616066-2020-02226
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Date of Event
    July 1, 2020
    Report Date
    July 2, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    07613203012430
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THERE WAS A HOLE IN TUBING CAUSING AIR IN LINE. RECEIVED ONE USED PRIMARY SET MODEL 2420-0500, LOT UNKNOWN. THE SET WAS SPIKED TO ONE 100ML BAXTER BAG (LOT P403790 EXP APR21, 0.9% SODIUM CHLORIDE) ATTACHED WITH ONE NOVAPLUS 3.375 VIAL (NDC 0781-9213-90 LOT KF6286 EXP DEC2021, PIPERACILLIN AND TAZOBACTAM). ONE ALCOHOL CAP WAS ATTACHED TO THE SET¿S MALE LUER. THE SET WAS VISUALLY INSPECTED FOR KINKS, INCOMPLETE BONDING ENGAGEMENTS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. VISUAL INSPECTION OBSERVED ONE TUBING CUT ON THE TUBING (P/N TC10012940) DUE TO A STAPLE LODGED IN THE TUBING. RESIDUAL DARK COLORED FLUID WAS OBSERVED NEAR THE AFFECTED AREA. NO OTHER ANOMALIES WERE OBSERVED. FUNCTIONAL TESTING WAS PERFORMED BY ATTACHING THE SET TO A LAB IV BAG WITH BLUE DYE WATER AND BY ALLOWING FLUID TO FLOW VIA GRAVITY. THE SET LEAKED FROM THE CUT TUBING THAT WAS NOTED DURING INSPECTION. NO OTHER LEAKS WERE OBSERVED THROUGHOUT THE SET OR ITS COMPONENTS. NO FURTHER TESTING COULD BE PERFORMED ON THE SET DUE TO THE DAMAGE IN THE TUBING. EQUIPMENT USED (MEASUREMENT AND TESTING PERFORMED ON 15SEP2020). OPTICAL RAM-CNC, EQ08204, CALIBRATION DUE DATE: 05FEB2021 . A DEVICE HISTORY RECORD COULD NOT BE PERFORMED DUE TO NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER¿S REPORT THAT THERE WAS A HOLE IN TUBING CAUSING AIR IN LINE WAS CONFIRMED DUE TO A CUT IN THE TUBING. BECAUSE THIS FAILURE HAD OCCURRED DURING USE AND NOT DURING PRIMING, IT IS PRESUMED THAT THE DAMAGE WAS NOT RELATED TO THE MANUFACTURING PROCESS. HOWEVER, CORRECTIVE ACTION (CAPA 723603) WAS CREATED TO ADDRESS THE ROOT CAUSES THAT ARE SPECIFIC TO THE BD/TIJUANA MANUFACTURING SITE. THE CAPA WAS CLOSED AS "EFFECTIVE" IN MITIGATING THIS DEFECT AND WILL CONTINUE TO BE MONITORED FOR AN INCREASE IN FREQUENCY. BD NOGALES MANUFACTURING FACILITIES HAS PREVIOUSLY INVESTIGATED VARIOUS STEPS OF THE MANUFACTURING AND SHIPPING PROCESSES WHERE DAMAGE COULD POTENTIALLY OCCUR. HOWEVER, IT WAS FOUND THAT THE ROOT CAUSE WAS DUE TO A STAPLE THAT WAS LODGED IN THE TUBING THAT OCCURRED DURING USE. THIS WAS CONSIDERED TO BE AN ISOLATED EVENT AND BD WILL CONTINUE TO MONITOR THIS ISSUE FOR ANY RISING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AS LVP 20D DEHP 2SS CV TUBING HAD A HOLE IN IT ALLOWING AIR IN THE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 2420-0500, BATCH(LOT) NO: UNKNOWN. IT WAS REPORTED THERE WAS A HOLE IN TUBING, CAUSING AIR IN LINE. ADDITIONAL INFORMATION (CUSTOMER RESPONSE) 07-JUL-2020: (B)(4). 1. WAS THE TUBING SET ATTACHED TO A PATIENT AT THE TIME OF THE EVENT OR OCCURRED DURING PREPARATION/PRIMING? WAS RUNNING TO A PATIENT AT THE TIME. 2. IF PATIENT INVOLVEMENT; WAS THERE ANY EFFECT ON THE PATIENT FROM THE EVENT? NO, OTHER THAN THE FLUID LEAKED OUT ON THE FLOOR SO PATIENT DID NOT GET ALL OF THE ANTIBIOTIC. THE ANTIBIOTIC WAS STILL ATTACHED TO THE LINE WHEN I TURNED IT IN, SO I AM UNSURE OF WHAT IT WAS. 3. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? PLEASE EXPLAIN: NOT THAT I AM AWARE OF. 4. WHAT WAS THE MEDICATION THAT WAS IN USE WHEN THE AIL WAS SEEN? AN ANTIBIOTIC. 5. WAS A BOTTLE OR BURETTE IN USE? THIS WAS A BAG, WHICH HAD AN ANTIBIOTIC BOTTLE ATTACHED. 6. WHAT WERE THE FLOW RATES BEING USED? UNSURE. 7. WHAT ARE YOUR AIR IN LINE SETTING CONFIGURATIONS ON YOUR PUMP? IS IT TOO SENSITIVE? THERE ARE TWO: 1) SINGLE BOLUS AND 2) ACCUMULATED (WHICH IS EITHER ENABLED OR DISABLED, DEPENDING ON YOUR HOSPITAL POLICY). THE OPTIONS ARE 50, 75, OR 250MCL. UNSURE. 8. IF PATIENT INVOLVEMENT, CAN YOU PLEASE PROVIDE THE FOLLOWING PATIENT INFORMATION: UNSURE. PATIENT INITIALS: PATIENT DATE OF BIRTH: PATIENT AGE: PATIENT GENDER: 1. LEAKING - APPEARS TO BE A PIN PRICK HOLE AT TOP OF BLUE CONNECTOR. 2. AIR IN LINE - AIR BUBBLE CORRECTED, A FEW MINUTES LATER, ANOTHER AIR BUBBLE WAS NOTED - LOOKS LIKE A SMALL HOLE WHERE BLUE CONNECTOR GOES IN TOP OF PUMP.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS LVP 20D DEHP 2SS CV TUBING HAD A HOLE IN IT ALLOWING AIR IN THE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 2420-0500 BATCH(LOT) NO: UNKNOWN. IT WAS REPORTED THERE WAS A HOLE IN TUBING, CAUSING AIR IN LINE. ADDITIONAL INFORMATION (CUSTOMER RESPONSE) 07-JUL-2020: PR 376448. WAS THE TUBING SET ATTACHED TO A PATIENT AT THE TIME OF THE EVENT OR OCCURRED DURING PREPARATION/PRIMING? WAS RUNNING TO A PATIENT AT THE TIME. IF PATIENT INVOLVEMENT; WAS THERE ANY EFFECT ON THE PATIENT FROM THE EVENT? NO, OTHER THAN THE FLUID LEAKED OUT ON THE FLOOR SO PATIENT DID NOT GET ALL OF THE ANTIBIOTIC. THE ANTIBIOTIC WAS STILL ATTACHED TO THE LINE WHEN I TURNED IT IN, SO I AM UNSURE OF WHAT IT WAS. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? PLEASE EXPLAIN: NOT THAT I AM AWARE OF. WHAT WAS THE MEDICATION THAT WAS IN USE WHEN THE AIL WAS SEEN? AN ANTIBIOTIC. WAS A BOTTLE OR BURETTE IN USE? THIS WAS A BAG, WHICH HAD AN ANTIBIOTIC BOTTLE ATTACHED. WHAT WERE THE FLOW RATES BEING USED? UNSURE. WHAT ARE YOUR AIR IN LINE SETTING CONFIGURATIONS ON YOUR PUMP? IS IT TOO SENSITIVE? THERE ARE TWO: 1) SINGLE BOLUS AND 2) ACCUMULATED (WHICH IS EITHER ENABLED OR DISABLED, DEPENDING ON YOUR HOSPITAL POLICY). THE OPTIONS ARE 50, 75, OR 250MCL. UNSURE. IF PATIENT INVOLVEMENT, CAN YOU PLEASE PROVIDE THE FOLLOWING PATIENT INFORMATION: UNSURE PATIENT INITIALS: PATIENT DATE OF BIRTH: PATIENT AGE: PATIENT GENDER:. LEAKING - APPEARS TO BE A PIN PRICK HOLE AT TOP OF BLUE CONNECTOR. AIR IN LINE - AIR BUBBLE CORRECTED, A FEW MINUTES LATER, ANOTHER AIR BUBBLE WAS NOTED - LOOKS LIKE A SMALL HOLE WHERE BLUE CONNECTOR GOES IN TOP OF PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785968 AS LVP 20D DEHP 2SS CV SET, ADMIN, INTRAVASCULAR FPA CAREFUSION 2420-0500 UNKNOWN 07613203012430

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 8015,8100, 20200701| 8015,8100, 20200701