BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS CLR POSITIVE DISPLACEMENT CONN

    MDR report key: 11121149 · Received January 5, 2021

    Report

    Report Number
    9616066-2020-20723
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Date of Event
    November 24, 2020
    Report Date
    January 15, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10/D11: CONCOMITANT MEDICAL PRODUCTS: DEVICE AVAILABLE FOR EVAL?: YES. D10/D11: CONCOMITANT MEDICAL PRODUCTS: RETURNED TO MANUFACTURER ON: 12/21/2020. H.6. INVESTIGATION: A MP1000C-0006 SAMPLE WAS RECEIVED FOR INVESTIGATION WITH RESIDUAL FLUID PRESENT WITHIN THE COMPONENT; THE CUSTOMER COULD NOT CONFIRM THE AFFECTED LOT, HOWEVER ANALYSIS OF THE LASER ID FROM THE SAMPLE INDICATES THE POSSIBLE AFFECTED LOT NUMBERS TO BE 20045450, 20045451 AND 20046048. A VISUAL INSPECTION IDENTIFIED A CRACK AT THE EDGE OF THE FEMALE LUER ADAPTOR OF THE MAXPLUS. LEAKAGE WAS OBSERVED FROM THE CRACK DURING A FLUSH THROUGH. A REVIEW OF THE PRODUCTION RECORDS FOR LOTS 20045450, 20045451 AND 20046048 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. PREVIOUS INVESTIGATIONS INTO COMPLAINTS OF THIS NATURE COULD NOT IDENTIFY A DEFINITIVE ROOT CAUSE FOR CRACKS TO THE LUER OF THE MAXPLUS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MAXPLUS CLR POSITIVE DISPLACEMENT CONN EXPERIENCED LUER-LOK COLLAR BREAKAGE AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NFC ATTACHED (B)(4) AND LEAK WAS OBSERVED ON (B)(4) IN THE PM. VISIBLE CRACK OBSERVED NEAR THE CONNECTION POINT. RED BUNG PLACED ON COMPLAINT SAMPLE TO SEE THE CRACK.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAXPLUS CLR POSITIVE DISPLACEMENT CONN EXPERIENCED LUER-LOK COLLAR BREAKAGE AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NFC ATTACHED 24TH NOV AND LEAK WAS OBSERVED ON 25TH NOV IN THE PM. VISIBLE CRACK OBSERVED NEAR THE CONNECTION POINT. RED BUNG PLACED ON COMPLAINT SAMPLE TO SEE THE CRACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17238 MAXPLUS CLR POSITIVE DISPLACEMENT CONN NEEDLE FREE CONNECTOR FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1