BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET, LIGHT SENSITIVE DRUG, REMOVABLE AFF VALVE

    MDR report key: 11598929 · Received March 31, 2021

    Report

    Report Number
    9616066-2021-50624
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    March 3, 2021
    Report Date
    March 26, 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
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: THE INITIAL REPORTER PROVIDED TWO INVALID LOT #S AS 12945216 AND 12882202. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: A 7290012271021 PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 12945216 OR 12882202. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE LEGAL MANUFACTURER OF THE PRODUCT, CAESAREA MEDICAL ELECTRONICS LTD. FOR INVESTIGATION. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 12945216 AND 12882202 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS AN ISOLATED OCCURRENCE WITH NO FURTHER REPORTS OF THIS NATURE AGAINST THE 7290012271021 PRODUCT OVER THE PAST 12 MONTHS. INVESTIGATION CONCLUSION: A 7290012271021 PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 12945216 OR 12882202.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IV SET, LIGHT SENSITIVE DRUG, REMOVABLE AFF VALVE EXPERIENCED DEFECTIVE/DAMAGED TUBING, AND WAS CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALARM WHICH IS 'DOWN OCCLUSION' HAS OCCURRED MANY TIMES ON BG INFUSION (323) PUMP. ACCORDING TO OUR INVESTIGATION, CLINICAL TRAINING IS DONE, LAST USER CAN SET INFUSION APPROPRIATELY AT HOSPITAL, THEY ENSURED THAT THERE WAS NO OCCLUSION OR KINK AFTER PUMP SEGMENT. THEY DETECTED THAT SET SILICONE SEGMENT HAD BEEN CRUSHED IN THE SECOND HOURS OF INFUSION, THE SET SILICONE SEGMENT STUCK TOGETHER BEFORE 48 HOURS. THEREFORE 'DOWN OCCLUSION ALARM' HAPPENED. THIS SITUATION NEGATIVELY AFFECTS TREATMENT AND HCP WORKFLOW. NICU AND CARDIOVASCULAR ICU WERE AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493880 IV SET, LIGHT SENSITIVE DRUG, REMOVABLE AFF VALVE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1