BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 24142669 · Received January 22, 2026

    Report

    Report Number
    2249723-2026-0000759
    Event Type
    Death
    Date Received
    January 22, 2026
    Date of Event
    December 30, 2025
    Report Date
    April 29, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION IN E1, EVENT SITE STATE: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELDS: D9, D10, AND G2. AN ESP TECHNICIAN REACHED OUT TO DISCUSS THE NATURE OF THE UNABLE TO CALIBRATE FIBER-OPTIC SENSOR ALARM. THEY COLLECTED COMPLAINT INFORMATION FOR ALL THE AVAILABLE PRODUCTS INVOLVED. THE NURSE EXPRESSED SOME CONCERN OVER THE FUNCTION OF THE PUMPS GOING INTO THE HOLIDAY STRETCH. THEY EXPLAINED THAT THE ALARMS WERE NOT INDICATIVE OF PUMP MALFUNCTION BUT MORE RELATED TO CATHETER/PATIENT FUNCTION BUT ENCOURAGED HER TO GET BIOMED TO ASSESS THE PUMPS AS SOON AS POSSIBLE. THEY ALSO PROVIDED CONTACT INFORMATION FOR OBTAINING A RENTAL AS AN ALTERNATIVE OPTION. THEY PROVIDED DIRECT CONTACT TO ANSWER ANY QUESTIONS ABOUT THE ALARMS TO BIOMED AS WELL. THEY APOLOGIZED FOR THE INABILITY TO CONNECT WITH THE OVERNIGHT ESP TEAM MEMBER ON CALL AND EXPLAINED THAT SHE HAD RECEIVED THE DISPATCHED CALL AND TRIED TO CONNECT MULTIPLE TIMES BUT NEVER RECEIVED AN ANSWER OR CALL BACK. THE NURSE STATED IT WAS DUE TO THE ONGOING CODE BLUE. THEY RECOMMENDED HAVING THE BEDSIDE NURSES USE THE MOST DIRECT CONTACT NUMBER FOR THE EMERGENCY SUPPORT CALL BACK NUMBER TO HAVE THE QUICKEST CALL BACK, EVEN IF THAT IS A CELL PHONE. SHE WAS APPRECIATIVE OF THE SUPPORT AND DENIED ANY FURTHER NEED. A BIOMED TECHNICIAN CALLED TO ASK ABOUT THE FUNCTION OF THE PUMPS. THE ESP TECHNICIAN EXPLAINED THE NATURE OF THE ALARM TO HIM AND ENCOURAGED HIM TO CALL THE CLINICAL SUPPORT AND REQUEST A SERVICE TECHNICIAN CALL IF HE NEEDED ONE. HE AGREED TO THE PLAN, AS HE DIDN¿T WANT TO ASSUME THE LIABILITY WITHOUT HAVING A GETINGE TECHNICIAN ASSESS THE PUMPS. HE HAD QUESTIONS ABOUT HOW LONG THE PROCESS TOOK FOR A FST TO BE DISPATCHED AND A RENTAL TO BE DELIVERED. THE TECHNICIAN WAS UNSURE OF THE ANSWER AND ENCOURAGED HIM TO CALL THE CLINICAL SUPPORT LINE AND FOLLOW THE APPROPRIATE PROMPTS. HE WAS APPRECIATIVE AND DENIED ANY FURTHER QUESTIONS. DURING EVALUATION OF THE FIRST UNIT BY A BIOMED TECHNICIAN IT WAS CONFIRMED IN THE FAULT LOGS THAT A GAS LOSS ALARM WAS IDENTIFIED. THE TECHNICIAN WAS UNABLE TO DUPLICATE THE FIBER OPTIC ALARM AS WELL AS THE GAS LOSS ALARM. PRODUCT INSPECTION WAS COMPLETED PER CUSTOMER/MANUFACTURER REQUIREMENTS. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY CHECKS. IT WAS STATED IN THE MEDICAL REVIEW, THE DEATH REPORTED IS NOT ASSIGNED TO THE SENSATION PLUS IAB CATHETERS, THE CARDIOSAVES OR THERAPY. WITH NO MALFUNCTION OR NEW HAZARD IDENTIFIED, ESCALATION OF THIS COMPLAINT IS NOT WARRANTED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H11. CORRECTED FIELDS: G1 (CONTACT OFFICE).

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER VIA EMERGENCY SUPPORT PROGRAM THAT A PATIENT DIED ON CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP). THE DEVICE HAD UNABLE TO CALIBRATE FIBER-OPTIC SENSOR ALARM FOLLOWED BY AN ACUTE DROP IN AUGMENTATION. THE CUSTOMER WAS UNSURE IF THE AUGMENTATION DROP CORRELATED WITH BLOOD PRESSURE. THEY EXCHANGED THE PUMP TO RESOLVE ALARM AND FLUSHED CATHETER BUT WAS SLUGGISH. CALLED CLINICAL SUPPORT LINE AT 1:54 AM EST BUT ESP TEAM MEMBER COULD NOT MAKE CONTACT WITH (B)(6) (THE BEDSIDE NURSE.) BETWEEN THE CALL BACK TIME, PATIENT BECAME UNRESPONSIVE AND CODE BLUE CALLED. PATIENT WAS GIVEN ACLS FOR AN UNKNOWN PERIOD OF TIME AND OBTAINED ROSC. CUSTOMER EXCHANGED BALLOON CATHETER, KEEPING PUMP 2 IN USE. THE ORIGINAL CATHETER WAS ACCIDENTALLY DISPOSED OF. MOMENTARY STABILIZATION OF PATIENT AFTER ACLS AND UNABLE TO CALIBRATE FIBER-OPTIC SENSOR ALARM RESOLVED. HOWEVER, AUGMENTATION DROPPED AGAIN, PATIENT BECAME UNRESPONSIVE AND CODE BLUE WAS CALLED FOR A SECOND TIME. FAMILY DECIDED TO NOT ESCALATE CARE AND PATIENT PASSED AWAY AT 3:44 AM EST. THE PATIENT HAD BEEN ADMITTED TO THE UNIT AFTER STENTING, DIAGNOSTICS, AND BALLOON PUMP PLACEMENT IN THE CCL. THE PATIENT HAD SEVERE AORTIC STENOSIS, MITRAL REGURG, TRICUSPID REGURG AND COUNTERPULSATION THERAPY WAS STARTED AS A BRIDGE TO TAVR DURING THE WORKUP PROCESS. CUSTOMER WAS UNSURE OF THE PATIENT¿S EF OR CI BUT AGREED THE PATIENT HAD MULTIPLE CARDIAC DIAGNOSES CONTRIBUTING TO POOR FUNCTION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203270 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 74 YR Male Death IAB CATHETER| SENSATION PLUS 50CC