BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 14103461 · Received April 13, 2022

    Report

    Report Number
    3010532612-2022-00110
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    March 14, 2022
    Report Date
    March 14, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    30801902051715
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THERE IS AN INVESTIGATION ONGOING INTO THIS REPORTED COMPLAINT. A SUPPLEMENT FOLLOW-UP MDR REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). NO IABP PART OR RECORDER STRIP WAS RETURNED TO TELEFLEX CHELMSFORD FOR INVESTIGATION. THE REPORTED COMPLAINT OF FREQUENT DRAIN FAILURE ALARMS IS NOT ABLE TO BE CONFIRMED. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. TELEFLEX ASSESSED THE RISK FOR THE REPORTED COMPLAINT. THERE ARE NO NEW OR REVISED RISK. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FREQUENT DRAIN FAILURE ALARMS OCCURRED DURING USE ON A PATIENT. THE CONDENSATION BOTTLE WAS EMPTY. HELIUM DRIVE LINE TUBING CLEAR AND DRY. THE STAFF TRIED MANUAL PURGE, THE PUMP WORKED FOR ABOUT 2 MINUTES AND ISSUED THE ALARM AGAIN. AS A RESULT, THE PUMP WAS SWAPPED OUT AND SENT TO BIOMED. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FREQUENT DRAIN FAILURE ALARMS OCCURRED DURING USE ON A PATIENT. THE CONDENSATION BOTTLE WAS EMPTY. HELIUM DRIVE LINE TUBING CLEAR AND DRY. THE STAFF TRIED MANUAL PURGE, THE PUMP WORKED FOR ABOUT 2 MINUTES AND ISSUED THE ALARM AGAIN. AS A RESULT, THE PUMP WAS SWAPPED OUT AND SENT TO BIOMED. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900819 AUTOCAT2 WAVE SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC IPN000320 N/A 30801902051715

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown