BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE SMARXT TUBING AND CONNECTORS

    MDR report key: 19871811 · Received July 31, 2024

    Report

    Report Number
    1718850-2024-00033
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    June 28, 2024
    Report Date
    November 15, 2024
    Manufacturer
    LIVANOVA USA INC.
    Product Code
    DWE
    PMA / PMN Number
    K981613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. H.10. LIVANOVA USA INC. MANUFACTURES THE CUSTOMIZED PERFUSION PACK. THE INCIDENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THEY HAVE EVEN TIE BANDED THESE CONNECTIONS. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H11: PICTURES WERE NOT AVAILABLE, AND THE SAMPLES WERE REQUESTED FOR INVESTIGATION, BUT WERE NEVER RECEIVED. REVIEW OF COMPLAINTS DATABASE REVEALED THAT A SIMILAR EVENT WAS RECORDED FOR THIS PERFUSION TUBING SYSTEM (PTS) PACK CODE IN THE PAST (REF. MFR#1718850-2023-00023), HOWEVER NO CONCERNING TREND RELATED TO THIS ISSUE HAS BEEN IDENTIFIED. BASED ON THE ABOVE, CONSIDERING THAT COMPLAINED CONNECTIONS ARE NOT PERFORMED IN LIVANOVA MANUFACTURING AND THAT NO PHYSICAL INVESTIGATION COULD BE PERFORMED ON AFFECTED UNITS, THE MOST LIKELY ROOT CAUSE OF THE EVENT WAS AN IMPROPER CONNECTION ASSEMBLED BY THE CUSTOMER AT THEIR FACILITY.

    Description of Event or Problem · 0

    LIVANOVA USA INC. RECEIVED A REPORT THAT SUCTION AND PRIME LINES OR LINES DISCONNECTED FROM A COMPETITOR RESERVOIR DURING SUPPORT. THERE IS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885042 COBE SMARXT TUBING AND CONNECTORS TUBING, PUMP, CARDIOPULMONARY BYPASS DWE LIVANOVA USA INC. 2326400039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown