BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE I PLUG

    MDR report key: 25174935 · Received May 14, 2026

    Report

    Report Number
    2249723-2026-0002664
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 15, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108421
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANOTHER CONTACT INFO: (B)(6). DUE TO CHARACTERIZATION LIMIT E1 INITIAL REPORTER: (B)(6). A GAS LOSS IN THE IAB CIRCUIT TAKES PLACE WHEN THE PUMP DETECTS A HELIUM LOSS DUE TO A LEAK OR HIGH RATE OF DIFFUSION IN THE IAB CIRCUIT. WHEN A CUMULATIVE SHUTTLE GAS LOSS EXCEEDS A NOMINAL 5 CC PER HR DYNAMIC LIMIT A GAS LOSS ALARM IS TRIGGERED. THE ALARM ACTIVATES ONLY WHEN THE IAB INFLATION PERIOD GREATER THAN OR EQUAL TO 80 MSEC AND DEFLATION PERIOD GREATER THAN OR EQUAL TO 250 MSEC. AN ECG TRIGGER IS USED WHEN THE PUMP SYNCHRONIZES INFLATION AND DEFLATION BASED ON THE PATIENT R WAVE. THE ECG SIGNAL CAN BE ACQUIRED DIRECTLY FROM SKIN ELECTRODES OR FROM AN EXTERNAL BEDSIDE MONITOR. THE SYSTEM ADAPTS THE DETECTION THRESHOLD TO CHANGES IN QRS AMPLITUDE AND SUPPRESSES MOTION ARTIFACT. PACER SPIKES ARE DISPLAYED AS GRAY VERTICAL LINES WHEN PACER TRIGGERING IS ACTIVE.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B1, B4, G3, G6, H2, H11. CORRECTED FIELDS: B7, H6 (MEDICAL DEVICE PROBLEM CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS). (B)(6), A CICU RN, REPORTED THROUGH THE EMERGENCY SUPPORT PROGRAM THAT THE CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) ALARMED TWICE FOR GAS LOSS DURING USE. SHE ADDRESSED THE ALARMS BY PRESSING THE IAB FILL KEY FOR TWO SECONDS EACH TIME, WHICH RESOLVED THE ISSUE. UPON ASSESSMENT, SHE CONFIRMED THERE WAS NO BLOOD, DISCOLORATION, OR DEBRIS IN THE HELIUM TUBING, AND ALL CONNECTIONS WERE SECURE. AT THE TIME, THE PATIENT WAS ON A VENTILATOR WITH A PEEP OF 8, REQUIRED FREQUENT SUCTIONING, AND WAS IN ATRIAL FIBRILLATION WITH A HEART RATE RANGING FROM THE 90S TO LOW 100S. THE ESP TEAM EXPLAINED THAT THE GAS LOSS ALARMS WERE LIKELY TRIGGERED BY A COMBINATION OF THESE CLINICAL FACTORS. (B)(6) ALSO NOTED THAT THE SYSTOLIC PRESSURE READING WAS EQUAL TO THE AUGMENTATION VALUE. A REVIEW OF THE IABP MONITOR SCREENSHOT SHOWED THE DEVICE WAS OPERATING IN SEMI AUTO MODE USING PRESSURE TRIGGERING, WITH ARTIFACT PRESENT IN THE ECG TRACING. ADDITIONALLY, A WHIP LIKE ARTIFACT WAS OBSERVED IN THE ARTERIAL WAVEFORM ALONG WITH AN ¿IRREGULAR PRESSURE DETECTED¿ MESSAGE. A CHEST X RAY IMAGE INDICATED THAT THE DISTAL MARKER WAS POSITIONED BETWEEN THE FIFTH AND SIXTH INTERCOSTAL SPACES. ESP PERSONNEL RECOMMENDED REPLACING THE ECG ELECTRODES, APPLYING DOPPLER GEL TO THEIR BACKS, AND POSITIONING THEM TO ¿HUG THE HEART¿ TO IMPROVE SIGNAL CONDUCTION. THEY ALSO ADVISED SWITCHING THE PUMP BACK TO AUTO MODE. NO PATIENT HARM OR INJURY WAS REPORTED. CAUSE RELATED TO PATIENT CONDITION: ECG BASED TRIGGERING MAY FAIL IN THE PRESENCE OF ARRHYTHMIAS SUCH AS ATRIAL FIBRILLATION, TACHYARRHYTHMIAS, OR EXTREMELY LOW AMPLITUDE QRS COMPLEXES. THESE CONDITIONS REDUCE THE PREDICTABILITY OR CLARITY OF THE ELECTRICAL SIGNAL, MAKING R WAVE DETECTION UNRELIABLE. ARTERIAL PRESSURE TRIGGERING MAY FAIL WHEN THE PATIENT EXHIBITS LOW PULSE PRESSURE, HEMODYNAMIC INSTABILITY, OVERDAMPED ARTERIAL WAVEFORMS, OR PHYSIOLOGIC CONDITIONS THAT DIMINISH SYSTOLIC UPSTROKE PROMINENCE. COLLECTIVELY, THESE CLINICAL CONDITIONS REDUCE THE RELIABILITY OF BOTH ECG AND PRESSURE SIGNALS USED FOR TRIGGERING. THE CAUSE IS THEREFORE ANTICIPATED PRODUCORIAL COMPLICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THROUGH EMERGENCY SUPPORT PROGRAM THAT THE CARDIOSAVE INTRA AORTIC BALLOON PUMP(IABP) GAS LOSS ALARM. NURSE REPORTED THE GAS LOSS ALARM HAD ALARMED TWO TIMES, AND SHE HAD TROUBLESHOT THE ALARM BY PRESSING THE IAB FILL KEY FOR TWO SECONDS, WHICH RESOLVED THE ALARM. NURSE CALLED THE CLINICAL LINE REQUESTING MORE INFORMATION ON THE GAS ALARM AND PROPER TROUBLESHOOTING STEPS. NURSE VERIFIED THERE WAS NO BLOOD, DISCOLORATION OR FLAKES IN THE HELIUM TUBING AND THAT ALL CONNECTIONS WERE SECURE. NURSE REPORTED THE PATIENT WAS ON A VENTILATOR WITH A PEEP OF 8, HAVING TO BE SUCTIONED FREQUENTLY, A HEART RHYTHM OF ATRIAL FIBRILLATION, AND A HEART RATE OF 90S TO LOW 100S. ESP PERSONNEL REVIEWED THE NATURE OF THE GAS LOSS ALARM AND EXPLAINED TO NURSE IT WAS LIKELY TRIGGERED BY THE COMBINATION OF THE ABOVE CLINICAL FACTORS. NURSE ALSO STATED THAT THE SYSTOLIC READING WAS EQUAL TO THE AUGMENTATION NUMBER. A SCREENSHOT OF THE IABP MONITOR REVEALED THE PUMP WAS IN SEMI AUTO MODE USING PRESSURE TRIGGER WITH ARTIFACT WITHIN THE ECG TRACING. IT ALSO REVEALED A WHIPPED LIKE ARTIFACT WITHIN THE ARTERIAL WAVEFORM AND AN IRREGULAR PRESSURE DETECTED MESSAGE. ESP PERSONNEL ALSO REVIEWED A SCREENSHOT OF THE MOST RECENT CHEST X RAY, WHICH REVEALED THE DISTAL MARKER WAS IN BETWEEN THE FIFTH AND SIX INTERCOSTAL SPACE. ESP PERSONNEL RECOMMENDED NURSE CONSULT THE PHYSICIAN REGARDING THE PLACEMENT. DR. (B)(6) WAS ALSO AT THE BEDSIDE AND STATED HE WOULD REVIEW THE CHEST X RAY AND COME UP WITH A PLAN FOR THE BALLOON CATHETER. IN THE MEANTIME, ESP PERSONNEL RECOMMENDED REPLACING THE ECG ELECTRODES, PLACING DOPPLER GEL ON THE BACK OF EACH ONE, AND PLACING THE ECG ELECTRODES AS IF THEY WERE HUGGING THE HEART TO INCREASE CONDUCTION, AND TO SWITCH BACK TO AUTO MODE. ESP PERSONNEL PROVIDED NURSE WITH DIRECT CONTACT INFORMATION AND ASKED HER OR THE PHYSICIAN TO CALL ME DIRECTLY SHOULD THEY HAVE ANY OTHER QUESTIONS OR THE NEED FOR TROUBLESHOOTING ASSISTANCE. NURSE APPRECIATED THE SUPPORT PROVIDED AND HAD NO OTHER QUESTIONS. NO PATIENT HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415313 CARDIOSAVE HYBRID, TYPE I PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-45 10607567108421

    Patients

    Seq Age Sex Outcome Treatment
    1