BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET AN126 W/O PUMP T-TYPE

    MDR report key: 12185892 · Received July 16, 2021

    Report

    Report Number
    9616066-2021-51544
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    June 17, 2021
    Report Date
    June 30, 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
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: A SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 2102231. THERE IS FOREIGN MATERIAL WAS FOUND IN THE IVSET CHAMBER. INFRARED SPECTROMETRY (IR) ANALYSIS: BASED ON IR ANALYSIS, THE FM IS SAME COMPONENT WITH RAW MATERIAL OF CHAMBER (POLYESTER) HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 RETENTION SAMPLES OF THE COMPLAINT PRODUCT (IV SET AN126 W/O PUMP T-TYPE, LOT NO. 2102102, 2102231 & 2104032), STORED IN THE COMPANY, THERE WAS NO DEFECTIVE PRODUCT FOUND IN THEM. DHR REVIEW: SBDM REVIEW THE MANUFACTURING RECORD OF COMPLAINT SAMPLE, THERE IS NO ISSUE WHILE MANUFACTURING. CUSTOMER COMPLAINT RECORD REVIEW: SBDM REVIEW THE CUSTOMER COMPLAINT RECORD OF COMPLAINT SAMPLE, THERE IS NO SIMILAR ISSUE OF THE SAME PRODUCT FROM OTHER CUSTOMER. ROOT CAUSE: ACCORDING TO THE INVESTIGATION RESULT, THE FM IS CARBIDE RAW MATERIAL OF CHAMBER WHICH WAS MADE WHILE THE RAW MATERIAL OF THE CHAMBER COMPONENTS ARE INJECTED IN THE INJECTION MACHINE IN HIGH TEMPERATURE (200¿~240¿). IT IS LIKELY THAT PVC(RAW MATERIAL OF CHAMBER COMPONENT) CARBIDE MAY BE FORMED IN THE HIGH TEMPERATURE OR STOCKED CARBIDE OF RAW MATERIAL ON THE DAMAGED POINT OF SCREW. THEREFORE THE CARBIDE WAS INJECTED WITH THE CHAMBER OF THE COMPLAINT I.V SET WHILE INJECTION PROCESS. HOWEVER, THE PROCESS INSPECTOR DID NOT FILE IT WHILE MANUFACTURING PROCESS AND IT CAUSED THIS COMPLAINT CASE. CORRECTIVE ACTIONS: QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR INJECTION MOLDING LINE WORKERS. IMPLEMENTING TIGHTENED PRODUCT & PROCESS MONITORING AND STRENGTHENING QUALITY INSPECTION FOR MOLDING MANUFACTURING PROCESS. CHECKED INJECTION MOLDING MACHINE FOR THE CHAMBER COMPONENT AND COMPLETED CLEANING OF THE SCREW & AROUND THE PRODUCTION AREAS AND MADE ARRANGEMENT ON THEM. CLEANING FREQUENCY: SCREW ¿ WEEKLY. AROUND THE MOLDING MACHINE ¿ DAILY (TWICE A DAY & WHEN DAY-NIGHT SHIFT IS CHANGED). GENERAL CLEANING OF MOLDING LINE - EVERY WEEK (LAST OPERATION DAY OF THE WEEK, FOR 2HOUR. AFTER SHUTDOWN). 24TH JUN. 2021 [CHAMBER INJECTION MACHINE]. CHANGED SCREW OF INJECTION MACHINE TO PREVENT CARBIDE OF RAW MATERIAL. IMPLEMENTING 100% VISUAL INSPECTION OF CHAMBER COMPONENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IV SET AN126 W/O PUMP T-TYPE EXPERIENCED FOREIGN MATTER IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATERIAL IN CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082012 IV SET AN126 W/O PUMP T-TYPE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 2102231

    Patients

    Seq Age Sex Outcome Treatment
    1