BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS LVP 20D LOW SORB 2SS 0.2M CV

    MDR report key: 11307030 · Received February 10, 2021

    Report

    Report Number
    9616066-2021-50186
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Date of Event
    January 14, 2021
    Report Date
    February 22, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403232341
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW FOR MODEL 11532269 LOT NUMBER 20115562 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF 7,683 UNITS IN 1 LOT NUMBER WAS BUILT ON (B)(6) 2020. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. ONE INFUSION SET WITH FILTER MATERIAL #: 11532269, BATCH/LOT #: 20115562 WAS PROVIDED BY CUSTOMER. THE ORIGINAL COMPLAINT WAS OF A SET MATCHING THE SAME BATCH WITH ISSUES OF LEAKAGE FROM THE FILTER. PHOTOS WERE PROVIDED BY CUSTOMER WHICH VERIFIED THE LEAKAGE. THE TWO RECEIVED SETS WERE TESTED WITH INFUSION OF BLUE DYE SOLUTION. THE MALE LUER END WAS THEN OCCLUDED AND BLUE DYE WAS THEN INJECTED INTO THE SET IN EFFORT TO FORCE THE GASKETS ON FILTER TO BLOW OUT. THE FILTERS RETAINED INTEGRITY AND THE ROOT CAUSE OF THIS FAILURE REMAINS UNKNOWN. IT IS TO BE KNOWN THOUGH, THAT WHEN ADMINISTERING DIFFERENT NUTRIENTS THROUGH FILTERED SETS, THAT SETS MUST BE SWITCHED IN SHORTER INTERVALS THAN THOSE OF REGULAR SOLUBLE MEDICATIONS/ SALINE SOLUTIONS. THIS COMPLAINT AND THE ONE SUBMITTED LIKE IT ALL DEALT WITH TPN AND THIS IS ALSO A NUTRIENT WHICH WILL SHORTEN THE PERIOD IN WHICH SET IS TO BE ACTIVE WITH PATIENT. WHEN LIPIDS ARE ADMINISTERED, THE SET SHOULD BE SWAPPED EVERY 12 HRS. CHECK WITH CUSTOMER ADVOCACY TO DETERMINE THE RECOMMENDED TIME FOR A GIVEN MEDICATION WHEN USING FILTERED SETS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AS LVP 20D LOW SORB 2SS 0.2M CV LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 11532269, BATCH/LOT #: 20115562 IT WAS REPORTED THAT A SPILL OF ABOUT 5 ML RESULTED AT THE COMPLETION OF THE INFUSION.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS LVP 20D LOW SORB 2SS 0.2M CV LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 11532269, BATCH/LOT #: 20115562. IT WAS REPORTED THAT A SPILL OF ABOUT 5 ML RESULTED AT THE COMPLETION OF THE INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205514 AS LVP 20D LOW SORB 2SS 0.2M CV INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 11532269 20115562 50885403232341

    Patients

    Seq Age Sex Outcome Treatment
    1