BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 23988424 · Received January 7, 2026

    Report

    Report Number
    2249723-2026-0000246
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    November 9, 2023
    Report Date
    April 26, 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

    DUE TO CHARACTER LIMITATION IN E1 FOR EVENT SITE NAME, THE FULL EVENT SITE NAME (B)(6). GAS LOSS IN IAB CIRCUIT: 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/HR DYNAMIC LIMIT A GAS LOSS ALARM IS TRIGGERED. THE ALARM ACTIVATES ONLY WHEN THE IAB INFLATION PERIOD >=80 MSEC AND DEFLATION PERIOD >=250 MSEC. GAS LOSS CAUSE: 1. PUMP SYSTEM MALFUNCTION: RESPONSE: SYSTEM VENTS AND IAB DEFLATES; ALARMS OCCUR IN ALL MODES. MITIGATION: IF NO LEAKS, OCCLUSIONS, OR PATIENT CONDITIONS (FEVER/TACHYCARDIA), PERFORM MANUAL IAB AUTOFILL USING FILL KEY (PURGES/REPLACES HELIUM AND RECALIBRATES). CONTRAINDICATIONS: SEVERE AORTIC INSUFFICIENCY, ANEURYSM, ADVANCED CALCIFIC DISEASE, OBESITY/GROIN SCARRING (AVOID SHEATH LESS INSERTION). RISK & LABELING: FAILURE MODE (NOT PRESSING FILL KEY) DOCUMENTED IN UFMEA; IFU PROVIDES CORRECTIVE STEPS. COMPLAINT HANDLING: DHR REVIEW REQUIRED ONLY UNDER SPECIFIC CRITERIA (MANUFACTURING DEFECT, SERIOUS INJURY/DEATH, REGULATORY REQUIREMENTS). CURRENT STATUS: NO DEVICE MALFUNCTION; NO CAPA/ESCALATION NEEDED; RISK WITHIN PROFILE. TREND REVIEW FOR ALL IAB PRODUCTS AND GAS GAIN/LOSS ALARM IS PERFORMED ON THE MONTHLY BASIS. IF ANY TRIGGERS ARE IDENTIFIED, THE TRIGGERS ARE DISCUSSED IN THE MONTHLY METRICS MEETING AND THE TRIGGERS IS INVESTIGATED IN THE CAPA REQUEST AS APPLICABLE. SINCE THERE WAS NO IAB OR IABP MALFUNCTION IDENTIFIED, NO CR/CAPA/SCAR REVIEW NEEDS TO BE PREFORMED AT THIS TIME. PER (B)(4) - CUSTOMER PRODUCT COMPLAINT INVESTIGATION, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) IS REQUIRED WHEN: FOR ALL COMPLAINTS ASSOCIATED WITH A SERVICEABLE DEVICE, WHERE THE DEVICE WAS MANUFACTURED WITHIN ONE (1) YEAR OF EVENT DATE OF THE COMPLAINT OR AWARE DATE (WHEN EVENT DATE IS NOT AVAILABLE). EXCEPTION: WHERE A MANUFACTURING DEFECT CAN BE CLEARLY RULED OUT, SUCH AS IN THE CASE OF CLEAR USE ERROR OR FOR COMPLAINTS THAT ARE RELATED TO FACILITY ISSUES (MALFUNCTION WAS CAUSED BY FACILITY ISSUE OR NO MALFUNCTION WAS OBSERVED ON OUR DEVICE, JUST SYMPTOMS OF FACILITY ISSUE, I.E. LACK OF POWER, WATER ETC.), A DHR REVIEW IS NOT REQUIRED. UFMEA REVIEW: PRODUCT RISK ANALYSIS DOCUMENTATION FOR CARDIOSAVE WAS REVIEWED FOR USER NOT PRESSING THE IAB FILL KEY. THIS ACTION IS CAPTURED UNDER "USE ERROR (FAILURE MODE)" AS "USERS FAILS TO MANUALLY INITIATE AN IAB AUTOFILL". (CARDIOSAVE UFMEA, (B)(4), REV C, (B)(4)) LABELLING REVIEW: CARDIOSAVE LABELING REVIEW IAB FILL KEY: REFER TO DOCUMENT NUMBER (B)(4) REV T,, SECTION 2.1.9 "AN OPERATOR MAY INITIATE AN AUTOFILL AT ANYTIME BY PRESSING AND HOLDING THE IAB FILL KEY. THIS WILL RESET THE 2 HOUR AUTOFILL TIMER. SHOULD A 2 HOUR AUTOFILL TIME-OUT OCCUR WHILE IN THE STANDBY MODE, AN AUTOFILL WILL BE PERFORMED ONE MINUTE AFTER RETURNING TO THE ASSIST MODE." AND 1.3.16 "SINCE THE IABP AUTOMATICALLY PURGES AND REPLACES THE SHUTTLE GAS EVERY 2 HOURS, OPERATOR INTERVENTION IS NOT NORMALLY REQUIRED. CONSEQUENTLY, THIS KEY IS USED INFREQUENTLY. TYPICALLY, IT IS USED IN CONJUNCTION WITH AN ALARM WHEN THE HELP SCREENS SUGGEST CORRECTIVE ACTION FOR ALARMS". CARDIOSAVE LABELING REVIEW GAS LOSS: REFER TO DOCUMENT NUMBER (B)(4) REV T, CARDIOSAVE OPERATING INSTRUCTIONS MANUAL, PAGE 2-33 FOR TROUBLESHOOTING WHEN THE IABP ALARMS "GAS LOSS IN IAB CIRCUIT". CURRENTLY THERE ARE NO ESCALATIONS REQUIRED. THE FAILURE MODE IS ADDRESSED IN THE RISK FILE AND IS OPERATING WITHIN ITS RISK PROFILE. THE IFU ADDRESSES THE REPORTED FAILURE. THE INVESTIGATION DOES NOT INDICATE THAT THE DEVICE WAS INADVERTENTLY RELEASED AS NON-CONFORMING OR AN ADULTERATED PRODUCT OR WAS A COUNTERFEIT.

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS ARE D10 CONCOMMITANT, E1 EVENT SITE STATE, E1 EVENT SITE POSTAL CODE, E1 EVENT SITE TELEPHONE, H6 TYPE OF INVESTIGATION, H6 COMPONENT AND H11. UPDATED FIELDS ARE B4, G3, G6, H2.ESP PERSONNEL WALKED HER THROUGH THE HELP SCREEN PROMPTS TO RESOLVE THE ISSUE: THE TUBING WAS CLEAR AND THE CONNECTIONS WERE TIGHT. SHE PRESSED IAB FILL AND RESTARTED THE PUMP WITHOUT ISSUE. ESP PERSONNEL EXPLAINED THE POSSIBLE CAUSES OF THIS ALARM. SHE STATED THAT THE PATIENT WAS NOT ON A VENTILATOR AND WAS RECEIVING HIGH FLOW OXYGEN ONLY. THE INSERTION SITE APPEARED NORMAL

    Description of Event or Problem · 0

    USER CALLED INTO EMERGENCY SUPPORT PROGRAM LINE TO REQUEST AND REPORT ISSUE DURING USE WITH CARDIOSAVE REGARDING GAS LOSS IN IAB CIRCUIT ALARM. THERE WAS PATIENT INVOLVEMENT AND NO HARM REPORTED.

    Description of Event or Problem · 0

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48610 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 UNKNOWN.| VENTILATOR.