BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7-DAY LL VLV ADPT(STAND ALONE)

    MDR report key: 10190844 · Received June 24, 2020

    Report

    Report Number
    9616066-2020-01937
    Event Type
    Malfunction
    Date Received
    June 24, 2020
    Date of Event
    June 4, 2020
    Report Date
    June 4, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K061285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES WERE RECEIVED FOR INVESTIGATION OF COMPLAINT REFERENCE INF-INT-2020-001286; HOWEVER THE CUSTOMER HAS INDICATED THAT THEY HAVE EXPERIENCED OCCLUSIONS WHEN USING THE 2000E7D PRODUCT FROM LOT 1012747. THE CUSTOMER HAS ALSO STATED THAT THE CONNECTING PRODUCTS WERE MEDRAD STELLANT PRODUCTS MANUFACTURED BY BAYER. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE; HOWEVER, THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED IN THIS INSTANCE AS NO SAMPLES WERE RECEIVED FOR INVESTIGATION. FURTHERMORE, THE LOT NUMBER WAS NOT AVAILABLE AND THEREFORE IT IS NOT POSSIBLE TO PERFORM A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THIS PARTICULAR PRODUCT. IN THIS INSTANCE, A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER'S EXPERIENCE COULD NOT BE DETERMINED; HOWEVER PREVIOUS REPORTS OF A SIMILAR NATURE HAVE BEEN FOUND TO BE RELATED TO FEATURES ON THE SURFACE OF THE MALE LUER OF THE CONNECTING PRODUCT. THESE FEATURES, INCLUDING FLASH OR A RAISED EDGE TO THE TIP OF THE MALE LUER, HAVE PREVIOUSLY BEEN SHOWN TO LEAD TO INTERMITTENT 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. HOWEVER AS NEITHER THE 2000E7D NOR THE CONNECTING PRODUCT IN CLINICAL USE AT THE TIME OF THE CUSTOMER'S EXPERIENCE WERE RECEIVED FOR INVESTIGATION, 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 HAVE BEEN A SMALL NUMBER OF SIMILAR REPORTS RECEIVED IN THE LAST TWELVE MONTHS; HOWEVER, TO DATE THESE COMPLAINTS HAVE NOT BEEN ATTRIBUTABLE TO A SMARTSITE® PRODUCT DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 7-DAY LL VLV ADPT(STAND ALONE) WAS HAVING REDUCED FLOW IN THE INFUSION PUMP. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TEAM ARE FACING PROBLEMS WHEN USING THIS MATERIAL ¿ REDUCED FLOW IN THE INFUSION PUMP WITH CONTRAST USE. CUSTOMER HAS SENT A VIDEO DEMONSTRATING THE TEST PERFORMED WITH SALINE SOLUTION 0,9% (BEFORE CONNECTION IN THE PATIENT). THE PROFESSIONALS REPORTED THERE IS NO PROPERLY FLOW AND THIS CAN BE VIEWED IN THE CHART AND PICTURES OF THE INJECTION PUMP. IT WAS ALSO REPORTED RESISTANCE DURING FLUSHING WITH SALINE SOLUTION 0,9%. IT WAS REPORTED THE USE OF EQUIPMENT LUER LOCK. QUANTITY AFFECTED: 3.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 7-DAY LL VLV ADPT (STAND ALONE) WAS HAVING REDUCED FLOW IN THE INFUSION PUMP. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TEAM ARE FACING PROBLEMS WHEN USING THIS MATERIAL ¿ REDUCED FLOW IN THE INFUSION PUMP WITH CONTRAST USE. CUSTOMER HAS SENT A VIDEO DEMONSTRATING THE TEST PERFORMED WITH SALINE SOLUTION 0,9% (BEFORE CONNECTION IN THE PATIENT). THE PROFESSIONALS REPORTED THERE IS NO PROPERLY FLOW AND THIS CAN BE VIEWED IN THE CHART AND PICTURES OF THE INJECTION PUMP. IT WAS ALSO REPORTED RESISTANCE DURING FLUSHING WITH SALINE SOLUTION 0,9%. IT WAS REPORTED THE USE OF EQUIPMENT LUER LOCK. QUANTITY AFFECTED: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654400 7-DAY LL VLV ADPT(STAND ALONE) VALVE FPA CAREFUSION 2000E7D UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200604| 20200604| 20200604.