BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS LVP 20D 3SS CV

    MDR report key: 10595745 · Received September 28, 2020

    Report

    Report Number
    9616066-2020-02810
    Event Type
    Malfunction
    Date Received
    September 28, 2020
    Date of Event
    September 4, 2020
    Report Date
    September 8, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FPA
    UDI-DI
    10885403227998
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: THE CUSTOMER REPORTED ¿THE TUBING WAS DEFECTIVE; HOLE IN THE STRETCHY PART OF THE TUBING¿. RECEIVED FROM THE CUSTOMER WAS ONE USED PRIMARY SET MODEL 2426-0007 LOT UNKNOWN. ATTACHED TO THE SET'S DRIP CHAMBER SPIKE, WAS A FULL 250 ML IV BAG OF 10% DEXTROSE INJECTION USP (BAXTER, LOT: Y324327, NDC 0338-0023-02, EXP: MAY21). RECEIVED WITH A COPY OF BD ¿CLINICAL ADVOCACY INCIDENT REPORT FORM¿. THE SET WAS VISUALLY INSPECTED FOR KINKS, INCOMPLETE BONDING ENGAGEMENTS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. A SMALL HOLE WAS OBSERVED IN THE SILICONE TUBING (P/N 12088541) JUST BELOW THE UPPER FITMENT (P/N TC10008721) RETAINER RING (P/N 601316-000). NO GOUGE/CRUSH MARKS WERE OBSERVED ON THE UPPER FITMENT. CLEAR LIQUID WAS OBSERVED IN THE SET¿S DRIP CHAMBER, AND ENTIRE LENGTH OF TUBING. NO OTHER ABNORMALITIES WERE OBSERVED WITH THE SET. ALTHOUGH DAMAGE WAS OBSERVED, FUNCTIONAL TESTING WAS PERFORMED BY USING THE RECEIVED IV BAG ALLOWING THE FLUID TO FLOW THROUGH THE SET VIA GRAVITY. THE FLUID WAS OBSERVED TO BE DRIPPING OUT OF THE LOCATION OF THE HOLE IN THE SILICONE SEGMENT TUBING. EQUIPMENT USED (VISUAL INSPECTION AND MEASUREMENT PERFORMED ON (B)(6) 2020): DINO LITE MICROSCOPE, EQ106199, NCR. OPTICAL RAM-CNC, EQ08204, CALIBRATION DUE DATE: 05-FEB-21. THE DEVICE HISTORY RECORD FOR PRIMARY SET MODEL 2426-0007 LOT UNKNOWN COULD NOT BE CONDUCTED BECAUSE THE LOT INFORMATION WAS NOT PROVIDED. ROOT CAUSE ANALYSIS: THE CUSTOMER'S REPORT OF A HOLE IN THE STRETCHY PART OF THE TUBING WAS CONFIRMED ON PRIMARY SET MODEL 2426-0007. THE HOLE WAS LOCATED IN THE SILICONE TUBING JUST BELOW THE UPPER FITMENT RETAINER RING. THE ROOT CAUSE OF THE HOLE COULD NOT BE DEFINITIVELY DETERMINED. HOWEVER, PREVIOUS INVESTIGATIONS HAVE SHOWN THAT THIS DAMAGE MAY BE A PRE-EXISTING CONDITION OF THE SILICONE RAW MATERIAL, OR CAN OCCUR DURING MANUFACTURING, SET LOADING, OR AS A RESULT OF EXCESSIVE STRETCHING OR PULLING OF THE TUBING DURING USE. INVESTIGATION CONCLUSION: PUMP SEGMENT ISSUES ARE CURRENTLY BEING INVESTIGATED AND WILL BE ADDRESSED UNDER SYSTEMIC FAILURE INVESTIGATION FOR PUMP SEGMENT (DIR 10000335005).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS LVP 20D 3SS CV TUBING WAS DEFECTIVE. THE AIR IN LINE ALARM WENT OFF AND THERE WAS LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 2426-0007; BATCH NO.: UNKNOWN. IT WAS REPORTED THE TUBING WAS DEFECTIVE; HOLE IN THE STRETCHY PART OF THE TUBING. PUMP ALARMING "AIR IN LINE", IV BAG EMPTY, PUDDLE OF FLUID FOUND ON FLOOR, HOLE IN THE STRETCHY PART OF TUBING. PHARMACY HAD TO MAKE NEW FLUIDS. RN HAD TO CHANGE FLUIDS TUBING, CHECK PT BLOOD SUGAR, FILL OUT PAPERWORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061803 AS LVP 20D 3SS CV INTRAVASCULAR ADMINISTRATION SET FPA CAREFUSION SD 2426-0007 UNKNOWN 10885403227998

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Other