BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 24758821 · Received April 1, 2026

    Report

    Report Number
    2249723-2026-0001978
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 10, 2026
    Report Date
    April 10, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, G3, G6, H2, H11. AFTER FURTHER REVIEW, AN INITIAL EMDR FOR THIS COMPLAINT WAS INCORRECTLY SUBMITTED. THIS IS A NON-REPORTABLE EVENT, MAKING IT NON-REPORTABLE TO THE FDA. AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. PLEASE CANCEL THIS REPORT 2249723-2026-0001978 IN YOUR DATABASE.

    Additional Manufacturer Narrative · 0

    OTHER CONTACT PHONE NUMBER: (B)(6). IT WAS REPORTED THROUGH THE EMERGENCY SUPPORT PROGRAM (ESP) THAT DURING USE OF THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP), THE USER EXPERIENCED DIFFICULTY UPDATING TIMING AND CONCERNS RELATED TO AUTO R-WAVE DEFLATION, ALONG WITH REDUCED AUGMENTATION. NO PATIENT HARM OR INJURY OCCURRED. TROUBLESHOOTING WAS PERFORMED WITH THE CLINICAL STAFF AND REVIEW OF DEVICE DATA SHOWED NO ACTIVE ALARMS AND APPROPRIATE VALUES AND WAVEFORMS. FURTHER ASSESSMENT DETERMINED THAT THE DEVICE AND CATHETER WERE FUNCTIONING AS INTENDED. THE OBSERVED BEHAVIOR WAS ATTRIBUTED TO PATIENT-RELATED FACTORS, INCLUDING FREQUENT PVCS, AND SUBOPTIMAL BALLOON POSITIONING, AS CONFIRMED BY CHEST X-RAY SHOWING THE RADIOPAQUE MARKER BELOW THE RECOMMENDED POSITION. ADDITIONAL GUIDANCE WAS PROVIDED REGARDING OPTIMAL BALLOON POSITIONING AND NURSING INTERVENTIONS. THE ISSUE WAS DETERMINED TO BE NOT RELATED TO A DEVICE MALFUNCTION, BUT RATHER DUE TO PATIENT CONDITION AND CATHETER POSITIONING.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE EMERGENCY SUPPORT PROGRAM (ESP) THAT DURING USE OF THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP), THE USER EXPERIENCED DIFFICULTY UPDATING TIMING AND REPORTED CONCERNS RELATED TO AUTO R WAVE DEFLATION ALONG WITH REDUCED AUGMENTATION. NO PATIENT HARM OR INJURY OCCURRED. TROUBLESHOOTING WAS PERFORMED WITH CLINICAL STAFF. REVIEW OF DEVICE DATA AND SCREENSHOTS SHOWED NO ACTIVE ALARMS AND DISPLAYED VALUES AND WAVEFORMS WITHIN EXPECTED RANGES. FURTHER ASSESSMENT DETERMINED THAT THE DEVICE AND CATHETER WERE FUNCTIONING AS INTENDED. THE OBSERVED BEHAVIOR WAS ATTRIBUTED TO PATIENT RELATED FACTORS INCLUDING FREQUENT PREMATURE VENTRICULAR CONTRACTIONS AND SUBOPTIMAL BALLOON POSITIONING. CHEST X RAY IMAGING SHOWED THE RADIOPAQUE MARKER POSITIONED BELOW THE RECOMMENDED LOCATION. ADDITIONAL GUIDANCE WAS PROVIDED REGARDING OPTIMAL BALLOON POSITIONING AND APPROPRIATE NURSING INTERVENTIONS. BASED ON THE INFORMATION AVAILABLE, THE ISSUE WAS DETERMINED NOT TO BE RELATED TO A DEVICE MALFUNCTION. THE EVENT WAS ATTRIBUTED TO PATIENT CONDITION AND CATHETER POSITIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819371 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 81 YR Male UNKNOWN.