BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCSN

    MDR report key: 19671078 · Received July 3, 2024

    Report

    Report Number
    3013095415-2024-00497
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    June 10, 2024
    Report Date
    June 11, 2024
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE BROKEN PATIENT CIRCUIT WAS NOT RETURNED TO VENTEC FOR EVALUATION. THE REPORTER ADVISED THAT IT HAD BEEN DISPOSED OF FOLLOWING THE EVENT. AS PART OF THE INVESTIGATION, VENTEC WAS ABLE TO DETERMINE THAT THE PATIENT CIRCUIT USED DURING THIS EVENT WAS OF THE NON-OVER MOLDED DESIGN. VENTEC HAD PREVIOUSLY REVIEWED HISTORICAL COMPLAINT DATA RELATED TO BROKEN CIRCUIT BOND JOINTS AND INITIATED AN INVESTIGATION TO DETERMINE ROOT CAUSE AND IDENTIFY ANY FURTHER ACTIONS TO CORRECT THE ISSUE AND PREVENT RECURRENCE. IT WAS OBSERVED THAT COMPLAINTS REPORTING BROKEN CIRCUITS WERE PRIMARILY HEATED CIRCUITS OF THE NON-OVER MOLDED DESIGN. PATIENT CIRCUITS THAT WERE IN VENTEC'S COMPLAINT RETENTION WHICH HAD PREVIOUSLY BEEN REPORTED AS HAVING BROKEN BOND JOINTS WERE EVALUATED BY VENTEC. THE VENTEC ENGINEERING TEAM REVIEWED EXPECTED USE CASES, MATERIALS, AND CONDUCTED ADDITIONAL TESTING TO UNDERSTAND POTENTIAL ROOT CAUSES AND CONTRIBUTING FACTORS. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE REPORTED ISSUE WAS POTENTIAL DEGRADATION OF LOCTITE 4601 STRENGTH IN THE POLYCARBONATE/POLYPROPYLENE CONNECTION DUE TO HIGH TEMPERATURE AND NEAR SATURATION HUMIDITY CONDITIONS. VENTEC CHANGED THE DESIGN OF THE PATIENT CIRCUIT TO AN OVER-MOLDED CONNECTION BACK IN 2020. VENTEC ALSO CONDUCTED A RISK ASSESSMENT BASED ON REASONABLY FORESEEABLE SEQUENCE OF EVENTS. THAT RISK ASSESSMENT CONCLUDED OVERALL RISK IS WITHIN ACCEPTABLE LIMITS. IF THE GLUE BOND WERE TO BREAK DURING USAGE, THE VOCSN SYSTEM HAS LEAK DETECTION MITIGATIONS SUCH AS THE PATIENT CIRCUIT DISCONNECT ALARM, LOW INSPIRATORY PRESSURE ALARM, AND LOW MINUTE VOLUME ALARM TO ALERT THE PATIENT, CAREGIVER AND/OR MEDICAL PERSONNEL.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VENTEC THAT A PATIENT CIRCUIT (PEDIATRIC, ACTIVE, HEATED, BLUE) BROKE DURING USE. THE REPORTER, A PEDIATRIC NURSE PRACTITIONER, ADVISED THAT SHE WAS ASSESSING A PATIENT IN THE NICU AND WHEN SHE MOVED THE PATIENT CIRCUIT IN ORDER TO ASSESS THE PATIENT'S LUNGS, THE CIRCUIT BROKE APART. THE PEDIATRIC NURSE PRACTITIONER THEN MANUALLY VENTILATED THE PATIENT UNTIL A RESPIRATORY THERAPIST COULD OBTAIN A REPLACEMENT PATIENT CIRCUIT. THE REPORTER ADVISED THAT THE PATIENT SURVIVED THE EVENT, HOWEVER, MEDICAL INTERVENTION WAS REQUIRED IN ORDER TO PREVENT PERMANENT IMPAIRMENT/DAMAGE TO THE PATIENT, AND THAT THEY NEEDED ESCALATION OF CARE/ICU. NO FURTHER DETAILS WERE PROVIDED. THE REPORTER ADVISED THAT THE BROKEN PATIENT CIRCUIT WAS DISPOSED OF FOLLOWING THE REPORTED EVENT. ADDITIONALLY, THE INITIAL REPORTER DID NOT PROVIDE THE VOCSN SERIAL NUMBER. AS A RESULT, SECTION D4 (MODEL #, CATALOG #, SERIAL # AND LOT #) REFLECTS THE INFORMATION KNOWN TO VENTEC ABOUT THE PATIENT CIRCUIT USED DURING THE EVENT. SECTION D4, UDI, IS "UNKNOWN" AND SECTION H4, DATE OF MANUFACTURER, SHALL BE LEFT BLANK. PLEASE NOTE, SECTION A4, WEIGHT, IS ACTUALLY 9.5 KG HOWEVER THE ESUB FORM DOES NOT ALLOW FOR DECIMALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977730 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-00803-000 218012

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Male Required Intervention