BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 23920140 · Received December 30, 2025

    Report

    Report Number
    2249723-2025-0005400
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    April 29, 2025
    Report Date
    April 23, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS ARE D10-CONCOMMITANT DEVICE, E1-EVENT SITE TELEPHONE, E1-EVENT SITE STATE, H6-MEDICAL DEVICE PROBLEM. UPDATED FIELDS ARE B4, G3, G6, H2, H6-(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION) AND H11. DJ, A RESPIRATORY THERAPIST IN THE ICU, WHO REQUESTED ASSISTANCE FOR AN UNABLE TO CALIBRATE ALARM ON A BALLOON PUMP. DJ STATED THAT NO NUMERIC VALUES WERE DISPLAYED ON THE PUMP AND MENTIONED THAT THE PATIENT HAD RECENTLY BEEN PLACED ON ECMO. UPON REVIEWING A SCREENSHOT, DJ WAS INSTRUCTED TO SWITCH THE ARTERIAL SOURCE TO THE TRANSDUCER. AFTER SWITCHING, HE WAS ABLE TO SUCCESSFULLY ZERO THE SYSTEM, AND APPROPRIATE WAVEFORM AND NUMERICAL VALUES WERE DISPLAYED. DJ THEN REPORTED AN UNABLE TO UPDATE TIMING ALARM. THE ALARM BEHAVIOR WAS REVIEWED AND EXPLAINED. DJ WAS ADVISED TO SWITCH THE PUMP TO SEMIAUTO MODE WITH ECG TRIGGER TO HELP REDUCE THE ALARM OCCURRENCE. IT WAS EXPLAINED THAT IF THE ECG LEADS BECAME UNREADABLE OR DISCONNECTED, THE PUMP WOULD ENTER STANDBY MODE. DJ ALSO MENTIONED THAT A PREVIOUS PUMP HAD INTERMITTENTLY OPERATED ON BATTERY POWER DESPITE BEING CONNECTED TO AC POWER. HE WAS INSTRUCTED TO PLACE THE PUMP INTO RESCUE CONFIGURATION AND THEN RETURN IT TO HYBRID CONFIGURATION. DJ STATED THAT HE WOULD CALL BACK IF THE PUMP SWITCHED TO BATTERY POWER AGAIN. DJ WAS PROVIDED WITH DIRECT CONTACT INFORMATION AND ENCOURAGED TO CALL WITH ANY ADDITIONAL QUESTIONS OR CONCERNS. HE EXPRESSED APPRECIATION FOR THE ASSISTANCE PROVIDED. NO CALLBACK WAS RECEIVED DURING THE REMAINDER OF THE SHIFT.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    USER CALLED INTO EMERGENCY SUPPORT PROGRAM LINE TO REQUEST AND REPORT ISSUE DURING USE WITH CARDIOSAVE REGARDING UNABLE TO CALIBRATE FIBER-OPTIC SENSOR ALARM / UNABLE TO UPDATE TIMING ALARM / BATTERY WILL NOT CHARGE. THERE WAS PATIENT INVOLVEMENT AND NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197391 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SENSATION PLUS 50 CC