BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 7125299 · Received December 18, 2017

    Report

    Report Number
    1828100-2017-00570
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Date of Event
    November 24, 2017
    Report Date
    March 29, 2018
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    PMA / PMN Number
    K153376
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED COMPLAINT WAS CONFIRMED. THE FIELD SERVICE REPRESENTATIVE (FSR) VERIFIED THE REPORTED COMPLAINT AND REPLACED DISPLAY ASSEMBLY. THE UNIT OPERATED TO THE MANUFACTURER¿S SPECIFICATIONS. DURING LABORATORY ANALYSIS, PRODUCT SURVEILLANCE TECHNICIAN (PST) CONNECTED THE SMALL DISPLAY ASSEMBLY TO A LAB USE ONLY (LUO) PUMP POD TEST FIXTURE AND OBSERVED NO DISPLAY WHEN POWER WAS APPLIED. IT WAS DETERMINED THAT THE GRAPHICS DRIVER PRINTED CIRCUIT BOARD (PCB) WAS THE CAUSE OF THE PROBLEM. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE DISPLAY ON THE ROLLER PUMP WENT BLANK. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: ON (B)(6) 2017, DURING A CPB PROCEDURE, THE CHIEF OF PERFUSION HAD A ROLLER PUMP LOOSE ITS LOCAL DISPLAY ON HIS HEART LUNG MACHINE (HLM). THE ROLLER PUMP WAS IN THE CARDIOPLEGIA (CPG) POSITION. HE WAS ABLE TO CONTINUE USAGE OF THE ROLLER PUMP AND CHOSE TO ADJUST THE FLOW OF THE CPG SOLUTION WITH THE CENTRAL CONTROL MONITOR (CCM) SLIDER. THE HLM IS DESIGNED TO HAVE REDUNDANCIES IN CASE OF A FAILURE, THEREFORE IN THIS CASE, THE TEAM WAS ABLE TO SAFELY AND FULLY GIVE THE CORRECT FLOW OF CPG TO THE MYOCARDIUM ALONG WITH THE CORRECT AMOUNT OF SOLUTION TO KEEP THE MYOCARDIUM ARRESTED DURING THE PROCEDURE. THIS INCIDENT DID NOT DELAY THE SURGICAL PROCEDURE, THE PATIENT WAS WEANED FROM CPB WITHOUT ISSUE. THERE WAS NO BLOOD LOSS, NOR HARM ASSOCIATED WITH THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905914 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 801040

    Patients

    Seq Age Sex Outcome Treatment
    1