BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC3 OPTIMUS IABP NA/EMEA

    MDR report key: 16306335 · Received February 6, 2023

    Report

    Report Number
    3010532612-2023-00076
    Event Type
    Malfunction
    Date Received
    February 6, 2023
    Date of Event
    January 30, 2023
    Report Date
    January 30, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    10801902172065
    PMA / PMN Number
    K162820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4), RETURNED FOR INVESTIGATION WAS AN AC3 FRONT END BOARD (FEB) (P/N: 33-1020-003, S/N: (B)(6)). THE SAMPLE WAS RETURNED IN AN FEB BOARD SHIPPING BOX WITH AN ELECTROSTATIC PROTECTIVE BAG. VISUAL INSPECTION OF THE FRONT END BOARD WAS PERFORMED AND NO ABNORMALITY WAS NOTED. THE CUSTOMER PROVIDED PHOTOS WERE REVIEWED. THE PHOTOS SHOWED IRREGULAR AP WAVEFORMS, WHICH IS CONSISTENT WITH THE REPORTED COMPLAINT. THE FRONT-END BOARD WAS INSTALLED INTO A KNOWN GOOD AC3 FOR FUNCTIONAL TESTING. THE PUMP WAS POWERED ON WITH NO ABNORMALITIES. A PATIENT SIMULATOR WAS CONNECTED TO THE PUMP AND PUMPING WAS INITIATED WITH AN AP TRIGGER IN OPERATOR MODE. THE FRONT END BOARD PASSED VOLTAGE CHECK, BP TRANSDUCER, AND STATIC RAM MEMORY. PERFORMED ECG, AP SIGNAL AND TRIGGER CHECKLIST AND PASSED. THE TRIGGER WAS SWITCHED FROM ECG TO AP WHILE PUMPING; THE HEART RATE REMAINED CONSISTENT, NO ABNORMALITIES WERE NOTED. THE PUMP WAS LEFT TO RUN FOR APPROXIMATELY 1 HOUR ON BATTERY POWER AND NO ALARMS OR ERRORS WERE NOTED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE SERIAL NUMBER/LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE RISK IS ACCEPTABLE. THE RETURNED DEVICE PASSED VISUAL AND FUNCTIONAL TESTING. THE REPORTED COMPLAINT OF "WHEN SWITCHING TO AP TRIGGER, HR DRAMATICALLY INCREASES AND PUMPING IS ERRATIC" IS NOT CONFIRMED. THE RETURNED FRONT-END BOARD PASSED VISUAL AND FUNCTIONAL TEST SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD (DHR), THE PRODUCT MET SPECIFICATION UPON RELEASE. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    REPORTED AS "LOSS OF AP TRIGGER WITH AP WAVEFORM AND PRESSURES PRESENT ON PUMP". IT WAS REPORTED THAT AN "INITIAL CALL TO THE HOTLINE FOR ASSISTANCE WITH DIFFICULTY PUMPING IN AP TRIGGER, WHEN SWITCHING TO AP TRIGGER, HR 'DRAMATICALLY INCREASES AND PUMPING IS ERRATIC'. TROUBLESHOOTING/ASSESSMENT DONE VIA FACETIME. LARGE AMOUNTS OF ARTIFACT NOTED ON AP WAVEFORM CAUSING ERRATIC TRIGGERING. PERFUSIONIST IS GETTING READY FOR WHEN BOVI IS USED. PUMP IS PUMPING APPROPRIATELY IN ECG TRIGGER. NO MOVEMENT OR INTERFERENCE NOTED ON TRANSDUCER OR AP TUBING, CABLE SWITCHED, RADIAL A-LINE CONNECTED BRIEFLY TO PUMP AND NO ARTIFACT NOTED ON RADIAL AP WAVEFORM. TRANSDUCER SET UP EXCHANGED, NO NOTED AP ARTIFACT. HOWEVER, WHEN ECG SIGNAL DISCONNECTED TO FORCE PUMP TO AP TRIGGER, TRIGGER LOSS ALARM OCCURRED, PUMPING STOPPED. PUMP SWITCHED BACK TO ECG WHEN PLUGGED BACK IN AND PUMPING RESUMED. THIS WAS REPEATED MULTIPLE TIMES WITH NO CHANGE. OPERATOR AND AUTOPILOT MODES ATTEMPTED. AP WAVEFORM PRESENT ON SCREEN, ACCURATE PRESSURES NOTED, PUMP NOT IDENTIFYING WAVEFORM. SECOND PUMP BROUGHT IN AND AP CABLE CONNECTED AND TRIGGER VERIFIED ON SECOND PUMP. PUMP EXCHANGED AND SENT TO BIOMED." NO PATIENT INJURY OR CONSEQUENCE. NO DELAY IN THERAPY.

    Description of Event or Problem · 0

    REPORTED AS "LOSS OF AP TRIGGER WITH AP WAVEFORM AND PRESSURES PRESENT ON PUMP". IT WAS REPORTED THAT AN "INITIAL CALL TO THE HOTLINE FOR ASSISTANCE WITH DIFFICULTY PUMPING IN AP TRIGGER, WHEN SWITCHING TO AP TRIGGER, HR 'DRAMATICALLY INCREASES AND PUMPING IS ERRATIC'. TROUBLESHOOTING/ASSESSMENT DONE VIA FACETIME. LARGE AMOUNTS OF ARTIFACT NOTED ON AP WAVEFORM CAUSING ERRATIC TRIGGERING. PERFUSIONIST IS GETTING READY FOR WHEN BOVI IS USED. PUMP IS PUMPING APPROPRIATELY IN ECG TRIGGER. NO MOVEMENT OR INTERFERENCE NOTED ON TRANSDUCER OR AP TUBING, CABLE SWITCHED, RADIAL A-LINE CONNECTED BRIEFLY TO PUMP AND NO ARTIFACT NOTED ON RADIAL AP WAVEFORM. TRANSDUCER SET UP EXCHANGED, NO NOTED AP ARTIFACT. HOWEVER, WHEN ECG SIGNAL DISCONNECTED TO FORCE PUMP TO AP TRIGGER, TRIGGER LOSS ALARM OCCURRED, PUMPING STOPPED. PUMP SWITCHED BACK TO ECG WHEN PLUGGED BACK IN AND PUMPING RESUMED. THIS WAS REPEATED MULTIPLE TIMES WITH NO CHANGE. OPERATOR AND AUTOPILOT MODES ATTEMPTED. AP WAVEFORM PRESENT ON SCREEN, ACCURATE PRESSURES NOTED, PUMP NOT IDENTIFYING WAVEFORM. SECOND PUMP BROUGHT IN AND AP CABLE CONNECTED AND TRIGGER VERIFIED ON SECOND PUMP. PUMP EXCHANGED AND SENT TO BIOMED." NO PATIENT INJURY OR CONSEQUENCE. NO DELAY IN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107524 AC3 OPTIMUS IABP NA/EMEA SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC IPN917285 N/A 10801902172065

    Patients

    Seq Age Sex Outcome Treatment
    1 Female