BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Y EXT W/VLV PORTS & 2 SLD CLP, 7 DAY

    MDR report key: 10703539 · Received October 20, 2020

    Report

    Report Number
    9616066-2020-20122
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    September 24, 2020
    Report Date
    November 11, 2020
    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: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2020-10-05. H6: INVESTIGATION SUMMARY: THREE (B)(6) SAMPLES FROM LOT 20075232 WERE RECEIVED FOR INVESTIGATION IN OPENED PACKAGING; RESIDUAL FLUID WAS PRESENT WITHIN THE SAMPLES. A VISUAL INSPECTION DID NOT IDENTIFY SIGNS OF DAMAGE OR MANUFACTURING DEFECTS WHICH COULD HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. THE SAMPLES WERE SUBJECTED TO FUNCTIONAL TESTING BY CONNECTING A 50ML BD PLASTIPAK SYRINGE FROM RETAINED BD STOCK TO EACH SMARTSITE COMPONENT AND FLUSHING WITH FLUID; NO OCCLUSION OR FLOW RESTRICTIONS WERE IDENTIFIED DURING TESTING. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. NO OBVIOUS MANUFACTURING DEFECTS WERE OBSERVED WHICH COULD HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE OF OCCLUSION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 20075232 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED IN THIS INSTANCE, AS A RESULT OF SIMILAR FEEDBACK THE MANUFACTURING SITE HAVE RAISED A REQUEST FOR CORRECTIVE AND PREVENTATIVE ACTIONS IN ORDER TO FURTHER INVESTIGATE A POTENTIAL ROOT CAUSE FOR OCCLUSIONS OF THIS NATURE. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH A SMALL NUMBER OF SIMILAR REPORTS AGAINST THE (B)(6) SET IN THE PAST 12 MONTHS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT Y EXT W/VLV PORTS & 2 SLD CLP, 7 DAY TUBING WAS BLOCKED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HIGH PRESSURE IN LINE NOT ALLOWING CLINICIANS TO PRIME. WHEN WE HAVE GONE TO PRIME THEM BEFORE CONNECTING THEM TO THE PATIENT THE THERE IS TOO MUCH PRESSURE AND IT WILL NOT ALLOW US TO PRIME THEM, SOMETIMES IF YOU TAKE THE END CAP OFF YOU CAN PRIME BUT THAT IS NOT IDEAL AND IT IS NOT ALWAYS THE CASE. THE FAULT HAS NOT IMPACTED ON A PATIENT BUT OBVIOUSLY WE ARE USING MORE STOCK THAN NORMAL. I WILL KEEP ANY FURTHER ONES FOR YOU. THANKS. (B)(6), DAY INFUSION CENTRE MANAGER. INTERNAL COMMENTS: SAMPLES CAN BE COLLECTED FROM SUPPLY DEPARTMENT AT JOHN FAWKNER HOSPITAL. PLEASE CONTACT (B)(6) SUPPLY MANAGER . (B)(6).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED . 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 Y EXT W/VLV PORTS & 2 SLD CLP, 7 DAY TUBING WAS BLOCKED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HIGH PRESSURE IN LINE NOT ALLOWING CLINICIANS TO PRIME. WHEN WE HAVE GONE TO PRIME THEM BEFORE CONNECTING THEM TO THE PATIENT THE THERE IS TOO MUCH PRESSURE AND IT WILL NOT ALLOW US TO PRIME THEM, SOMETIMES IF YOU TAKE THE END CAP OFF YOU CAN PRIME BUT THAT IS NOT IDEAL AND IT IS NOT ALWAYS THE CASE. THE FAULT HAS NOT IMPACTED ON A PATIENT BUT OBVIOUSLY WE ARE USING MORE STOCK THAN NORMAL. I WILL KEEP ANY FURTHER ONES FOR YOU. THANKS, (B)(6). INTERNAL COMMENTS: SAMPLES CAN BE COLLECTED FROM SUPPLY DEPARTMENT AT (B)(6) HOSPITAL. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169788 Y EXT W/VLV PORTS & 2 SLD CLP, 7 DAY INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 20075232

    Patients

    Seq Age Sex Outcome Treatment
    1