BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    16 IN NON-DEHP STANDARD BORE EXT SET

    MDR report key: 10222298 · Received July 1, 2020

    Report

    Report Number
    9616066-2020-02061
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Date of Event
    June 8, 2020
    Report Date
    June 10, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FPA
    UDI-DI
    10885403237669
    PMA / PMN Number
    K051499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THE FILTER WAS LEAKING IV FLUID FROM THE FLAT BACK SIDE OF FILTER. RECEIVED FROM THE CUSTOMER ARE TWO FILTER EXTENSION SETS MODEL MX9171, LOT UNKNOWN. EACH SET WAS RECEIVED WITH A GREEN ALCOHOL DISINFECTING CAP ATTACHED. ALSO RECEIVED IS A 10ML BD SYRINGE (LOT NUMBER: 0062230, EXP: (B)(6) 2023. THE SETS WERE VISUALLY INSPECTED FOR KINKS, INCOMPLETE BONDING ENGAGEMENTS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. NO ANOMALIES WERE OBSERVED WITH THE RECEIVED SETS DURING VISUAL INSPECTION. FUNCTIONAL TESTING WAS PERFORMED BY FILLING A LAB SYRINGE WITH BLUE DYE WATER AND FLUSHING FLUID THROUGH EACH SET VIA FLUSH. FLUID FLOWED THROUGHOUT EACH SET AND NO LEAKS AT THE FILTER OR ANYWHERE ELSE THROUGHOUT THE SETS WERE OBSERVED. THE SETS WERE LOADED INTO A LAB SYRINGE PUMP MODULE FOR AN INFUSION TEST. THE PRIMARY INFUSION WAS PROGRAMMED AT A RATE OF 10ML/H AND 10ML VTBI. THE INFUSION COMPLETED WITH NO LEAKS OBSERVED AT THE FILTER OR ANYWHERE ELSE THROUGHOUT THE SETS. THE SETS WERE THEN PRESSURE TESTED WHILE SUBMERGED UNDERWATER (PER DIR # (B)(4), DISPOSABLE LEAK TEST TP CAD). AIR PRESSURE WAS INCREMENTALLY INCREASED FROM 5 PSI TO 30 PSI. THERE WERE NO SIGNS OF LEAKING ANYWHERE ON THE RETURNED SETS WHILE THE TUBING WAS MANIPULATED AT EACH ENGAGEMENT. EQUIPMENT USED FOR TESTING PERFORMED ON (B)(6) 2020: 8110 ALARIS SYRINGE MODULE #1, EQ08313, (B)(6) 21. 8015 ALARIS PCU 1.5 #1, EQ08330, (B)(6) 21. AIR PRESSURE REGULATOR WITH PRESSURE GAUGE #2, EQ00138, CALIBRATION DUE (B)(6) 2020. DEVICE HISTORY RECORD FOR MODEL MX9171 COULD NOT BE PERFORMED DUE TO NO LOT NUMBER BEING PROVIDED BY CUSTOMER. THE CUSTOMER¿S REPORT OF A LEAK FROM THE FILTER WAS NOT CONFIRMED. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT COULD NOT BE IDENTIFIED BECAUSE NO LEAKS OCCURRED WITH THE RECEIVED SETS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 16 IN NON-DEHP STANDARD BORE EXT SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE SEEMED TO HAVE HAD AN ISSUE WITH DEFECTIVE PRODUCT. THE LOT NUMBER AND THE PACKAGING HAS BEEN DISCARDED. THE SET IS BEING KEPT IN A PLASTIC BAG. NEW INFORMATION RECEIVED: CAN YOU BE MORE SPECIFIC ABOUT THE TWO INCIDENTS YOU ARE TALKING ABOUT IN YOUR EMAIL. I.E. WAS THERE PATIENT INVOLVEMENT? YES, FLUID WAS LEAKING WHILE CONNECTED TO PATIENT¿S CENTRAL LINE.

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: ONLY THE PATIENT'S AGE WAS GIVEN THEREFORE A DEFAULT DATE OF BIRTH HAS BEEN LISTED. 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 THE 16 IN NON-DEHP STANDARD BORE EXT SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE SEEMED TO HAVE HAD AN ISSUE WITH DEFECTIVE PRODUCT. THE LOT NUMBER AND THE PACKAGING HAS BEEN DISCARDED. THE SET IS BEING KEPT IN A PLASTIC BAG. NEW INFORMATION RECEIVED: CAN YOU BE MORE SPECIFIC ABOUT THE TWO INCIDENTS YOU ARE TALKING ABOUT IN YOUR EMAIL. I.E. WAS THERE PATIENT INVOLVEMENT? YES- FLUID WAS LEAKING WHILE CONNECTED TO PATIENT¿S CENTRAL LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680533 16 IN NON-DEHP STANDARD BORE EXT SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. UNKNOWN 10885403237669

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Other (B)(4).| (B)(4).