BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 17692482 · Received September 6, 2023

    Report

    Report Number
    3010532612-2023-00502
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Date of Event
    August 20, 2023
    Report Date
    August 20, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    30801902051715
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE REPORTED COMPLAINT OF EXCESSIVE CONDENSATION BUILDUP IS NOT ABLE TO BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD (DHR), THE PRODUCT MET SPECIFICATION UPON RELEASE. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. THE REPORTED COMPLAINT WILL BE MONITORED FOR ANY DEVELOPING TRENDS. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Description of Event or Problem · 0

    REPORTED AS "EXCESSIVE CONDENSATION BUILDUP IN THE HELIUM DRIVE LINE TUBING, PRESSURES NOT CONSISTENT ON THE PUMP". THE REPORT STATES, "EXCESSIVE CONDENSATION NOTED IN THE HELIUM DRIVELINE TUBING. IT IS CLEAR WITHOUT ANY EVIDENCE OF BLOOD. THE CONDENSATION COLLECTION BOTTLE IS EMPTY. THE PATIENT DOES HAVE A BEAR HUGGER ON AND INITIALLY THOUGHT THIS MAY BE CONTRIBUTING TO THE CONDENSATION. THE BEAR HUGGER WAS TURNED OFF FOR OVER AN HOUR AND THE CONDENSATION CONTINUED TO BUILD UP. THE AP WOULD READ CORRECTLY IMMEDIATELY AFTER LEVELING AND ZEROING THE TRANSDUCER BUT WOULD QUICKLY START READING 240/160 WHEN THE PATIENT'S PRESSURES WERE 100/50 AND LOWER". AS A RESULT, THE PUMP WAS SWAPPED OUT FOR ANOTHER. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "CRITICAL".

    Description of Event or Problem · 0

    REPORTED AS "EXCESSIVE CONDENSATION BUILDUP IN THE HELIUM DRIVE LINE TUBING, PRESSURES NOT CONSISTENT ON THE PUMP". THE REPORT STATES, "EXCESSIVE CONDENSATION NOTED IN THE HELIUM DRIVELINE TUBING. IT IS CLEAR WITHOUT ANY EVIDENCE OF BLOOD. THE CONDENSATION COLLECTION BOTTLE IS EMPTY. THE PATIENT DOES HAVE A BEAR HUGGER ON AND INITIALLY THOUGHT THIS MAY BE CONTRIBUTING TO THE CONDENSATION. THE BEAR HUGGER WAS TURNED OFF FOR OVER AN HOUR AND THE CONDENSATION CONTINUED TO BUILD UP. THE AP WOULD READ CORRECTLY IMMEDIATELY AFTER LEVELING AND ZEROING THE TRANSDUCER BUT WOULD QUICKLY START READING 240/160 WHEN THE PATIENT'S PRESSURES WERE 100/50 AND LOWER". AS A RESULT, THE PUMP WAS SWAPPED OUT FOR ANOTHER. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "CRITICAL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224169 AUTOCAT2 WAVE SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC 30801902051715

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown