BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL VLV ADPT(STAND ALONE)

    MDR report key: 10144555 · Received June 11, 2020

    Report

    Report Number
    9616066-2020-01932
    Event Type
    Malfunction
    Date Received
    June 11, 2020
    Date of Event
    May 21, 2020
    Report Date
    May 21, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A 2000E (B)(6) PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 19065676. FURTHER INFORMATION PROVIDED BY THE CUSTOMER CONFIRMED ONE OF THE CONNECTING PRODUCTS WAS A BD INTIMA II. INVESTIGATION CONCLUSION: THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 19065676 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. PLEASE NOTE THAT PREVIOUS COMPLAINTS FOR OCCLUSIONS HAVE BEEN RELATED TO FEATURES ON THE SURFACE OF THE MALE LUER OF THE CONNECTING PRODUCTS. THESE FEATURES INCLUDE FLASH OR A RAISED EDGE TO THE TIP OF THE MALE LUER WHICH HAVE PREVIOUSLY BEEN SHOWN TO INTERMITTENTLY LEAD TO RESTRICTED FLOW DUE TO THEM PINCHING THE BLUE PISTON OF THE SMARTSITE AND NOT ALLOWING IT TO OPEN. THIS CAN SOMETIMES BE RESOLVED BY DISCONNECTING AND REATTACHING THE SAME LUER CONNECTION WHICH MAY REPOSITION THE LUER AGAINST THE PISTON AND IMPROVE THE FLOW, OR ALTERNATIVELY BY CHANGING THE CONNECTING MALE LUER. IN THIS INSTANCE THE CONNECTING PRODUCT IN USE AT THE TIME OF THE CUSTOMER'S EXPERIENCE WAS NOT AVAILABLE FOR INVESTIGATION AND THEREFORE IT HAS NOT BEEN POSSIBLE TO CONFIRM IF THIS MAY HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THERE ARE A SMALL NUMBER OF SIMILAR REPORTS; HOWEVER, THESE COMPLAINTS HAVE NOT BEEN ATTRIBUTABLE TO A SMARTSITE PRODUCT DEFECT. ROOT CAUSE DESCRIPTION: DHR FOR THIS COMPLAINT: (B)(4) LOT: 19065676 MODEL: 2000E (B)(6) QTY: 60,000 QN/DEVIATION: NONE MFG DATE: 10-JUN-2019 2000E (B)(6)/NO 510K THIS IS AN INTERNATIONAL CODE- THE MODEL#/CATALOG# IDENTIFIED IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE DOMESTIC SIMILAR LIST NUMBER IS 2000E. THE 510K NUMBER PROVIDED IS FOR THE DOMESTIC SIMILAR PRODUCT. K960280.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LL VLV ADPT(STAND ALONE) WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A BLOCKAGE WAS FOUND IN THE SMARTSITE CONNECTOR AT THE HEPATOBILIARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607125 LL VLV ADPT(STAND ALONE) INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. 19065676

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200521