BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS LVP 20D LOW SORB 2SS 0.2M CV

    MDR report key: 11829636 · Received May 14, 2021

    Report

    Report Number
    9616066-2021-51033
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    April 15, 2021
    Report Date
    May 3, 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
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED FOR QUALITY INVESTIGATION. THE CUSTOMER COMPLAINT OF FOREIGN MATTER - SPOTS WAS VERIFIED BY VISUAL INSPECTION. VISUAL EVALUATION OF THE SAMPLE RECEIVED SHOWS A DARK BROWN SUBSTANCE WITHIN THE SPIKE COVER OF THE DRIP CHAMBER SPIKE. A DEVICE HISTORY RECORD REVIEW FOR MODEL 11532269 LOT NUMBER 20057066 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 30MAR2020. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. THE ROOT CAUSE FOR THIS ISSUE IS THAT THERE IS GREASE THAT REMAINS FROM THE MANUFACTURING PROCESS OF THE DRIP CHAMBER MOLDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A AS LVP 20D LOW SORB 2SS 0.2M CV HAD FOREIGN MATTER BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: 'IT WAS REPORTED THAT THE SPIKE AREA OF THE INFUSION SET WAS LACED WITH UNKNOWN BLACK SPECKS INSIDE THE CAP. VERBATIM: MY NAME IS XXXXX XX, A MEDICATION SAFETY PHARMACIST AT OHIOHEALTH GRANT MEDICAL CENTER. OUR IV TECHNICIAN WAS SETTING UP HER COMPONENTS TO COMPOUND/PRIME A CHEMOTHERAPY IN THE MORNING OF 4/15, AFTER SHE TORN OPEN THE OUTER PACKAGE, SHE NOTICED THE SPIKE AREA OF THE 0.2 MICRON FILTER INFUSION SET WAS LACED WITH UNKNOWN BLACK SPECKS INSIDE THE CAP. THE INFUSION SET WAS IMMEDIATELY SET ASIDE/SEQUESTERED. ALL OTHER SUPPLIES WERE CHECKED FOR SIMILAR POTENTIAL CONTAMINANTS AND NONE WERE NOTED. NO PATIENT WAS AFFECTED. REF: 11532269. LOT: (10)20057066. EXP: (17) 2023-05-30. UPON CLOSER EXAMINATION, IT SEEMS THAT THE CHAMBER ALSO HAS SOME BROWN SPECKS IN THEM. BUT AFTER COMPARING IT WITH ANOTHER NEW SET, IT APPEARS THAT THE BROWN SPECKS ARE ALSO PRESENT. SO IS IT NORMAL? WE REMOVE THE INFUSION SETS FROM THE CARTON, WIPE THEM DOWN, AND STOCK INSIDE DEDICATED BINS WITHIN THE NEGATIVE PRESSURED IV CLEAN ROOM. TO MY KNOWLEDGE, NO ONE HAS UNCAPPED THE SPIKE AFTER THE DISCOVERY. OUR BIG CONCERN IS IF IT COULD BE MOLD, ESPECIALLY WHEN ITS FOUND WITHIN THE AREA SERVING THE IMMUNOCOMPROMISED POPULATION. THE ITEM IS AVAILABLE FOR RETRIEVAL, AND IM WONDERING IF THOSE CAN BE ANALYZED/INVESTIGATED. LET ME KNOW IF THERE HAS BEEN REPORTS SIMILAR TO THIS AND IF ITS A CONCERN FOR US TO QUARANTINE THE SAID PRODUCT UNTIL INVESTIGATION IS CONCLUDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725702 AS LVP 20D LOW SORB 2SS 0.2M CV INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 11532269 20057066 50885403232341

    Patients

    Seq Age Sex Outcome Treatment
    1