BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE

    MDR report key: 22674581 · Received July 31, 2025

    Report

    Report Number
    2249723-2025-0003294
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    July 13, 2025
    Report Date
    November 12, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION, EVENT SITE FULL NAME: HCA-OGDEN REGIONAL MEDICAL CENTER A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, D7A, D9, G3, G4, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELD: B5, G2, H6 MEDICAL DEVICE PROBLEM CODE. ESP PERSONNEL WAS ON CALL TO EVALUATE AND TROUBLESHOOT THE UNIT. THE PERSONNEL REPORTED THAT THE CUSTOMER TRIED TO TROUBLESHOOT ON THEIR OWN AND IT DID NOT GET ANY BETTER. THE CUSTOMER CONFIRMED WITH THE CARDIOLOGIST ON THE PLACEMENT AND SAID IT WAS OKAY. THE CUSTOMER SENT AN IMAGE OF THE CONSOLE SCREEN WHICH SHOWED THE PUMP IN 1:2 WITH ASSISTED PRESSURES OF 88/49 (69), UNASSISTED 95/52, AND AUGMENTATION OF 93. PERSONNEL REQUESTED AN IMAGE IN 1:1 AND ALL THE WAVEFORMS APPEARED STABLE, CONSISTENT, AND WITH NO ARTIFACT, PRESSURES OF 85/49 (71), AND AN AUGMENTATION OF 86. TROUBLESHOOTING WITH PERSONNEL INCLUDED REPLACING THE ELECTRODES, FLUSHING THE INNER LUMEN WITH THE PUMP IN STANDBY, AND VERIFYING PLACEMENT VIA THE MOST RECENT X-RAY IMPRESSION. AFTER TROUBLESHOOTING, THE NUMBERS AD WAVEFORMS WERE LIKE THE BEGINNING OF THE ESP CALL. PERSONNEL RECOMMENDED PLACEMENT BETWEEN THE 2ND AND 3RD INTERCOSTAL SPACE, THE CUSTOMER WOULD NOTIFY THE CARDIOLOGIST OF THE RECOMMENDATIONS. MORE DATA COLLECTION DETERMINED THE PATIENT WAS ON SEVERAL IV INFUSIONS, INCLUDING FENTANYL, HEPARIN, HIGH DOSE LEVOPHED, DOPAMINE, AMIODARONE, PROPOFOL, INSULIN, AND NIMBEX. PERSONNEL REVIEWED FACTORS AFFECTING AUGMENTATION INCLUDING HEMODYNAMICS AND PRESSOR SUPPORT, IT WAS ENCOURAGED TO REACH OUT TO THE ATTENDING TO DISCUSS FURTHER PLAN OF CARE TO OPTIMIZE THERAPY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD ISSUE FOR SUBOPTIMAL AUGMENTATION AND ECG QUALITY WAVEFORM IT WAS STATED THAT ¿IT HAS BEEN GIVING US ISSUES, SO WE WENT TO 1:2 BECAUSE WHEN WE¿RE IN 1:1, IT ALMOST WENT FLAT, AN IMAGE OF THE CONSOLE SCREEN SHOWED THE PUMP IN 1:2 WITH ASSISTED PRESSURES OF 88/49 (69), UNASSISTED 95/52, AND AN AUGMENTATION OF 93. 2 UBEDS WERE PRESENT IN THE IMAGE AS WELL. ALL THE WAVEFORMS APPEARED STABLE, CONSISTENT, AND WITH NO ARTIFACT, PRESSURES OF 85/49 (71), AND AN AUGMENTATION OF 86. IN SHARED IMAGES TROUBLESHOOTING INCLUDED REPLACING THE ELECTRODES, FLUSHING THE INNER LUMEN WITH THE PUMP IN STANDBY, AND VERIFYING PLACEMENT VIA THE MOST RECENT X-RAY IMPRESSION. AFTER LEAD REPLACEMENT AND FLUSHING, THE NUMBERS AND WAVEFORMS WERE LIKE THE BEGINNING OF THE CALL. THE MOST RECENT X-RAY WAS SATISFACTORY PER THE CARDIOLOGIST, AS THE CATHETER HAD BEEN REPOSITIONED AFTER THE MORNING CHEST X-RAY. I REINFORCED OUR RECOMMENDATIONS FOR PLACEMENT, BETWEEN THE 2ND AND 3RD INTERCOSTAL SPACE. CUSTOMER REVIEWED THE IMAGE AND STATED IT LOOKED LIKE IT WAS AT THE 3RD INTERCOSTAL BUT THAT SHE WOULD NOTIFY THE CARDIOLOGIST OF OUR RECOMMENDATIONS. FURTHER DATA COLLECTION DETERMINED THE PATIENT WAS ON SEVERAL IV INFUSIONS, INCLUDING FENTANYL, HEPARIN, HIGH DOSE LEVOPHED, DOPAMINE, AMIODARONE, PROPOFOL, INSULIN, AND NIMBEX. SHE WAS UNAWARE OF THE PATIENT¿S EF, CO, OR SVR.

    Description of Event or Problem · 0

    THIS ISSUE WAS REPORTED THROUGH EMERGENCY SUPPORT LINE. IT WAS REPORTED THAT DURING USE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD ISSUE FOR SUBOPTIMAL AUGMENTATION AND ECG QUALITY WAVEFORM. IT WAS STATED THAT ¿IT HAS BEEN GIVING US ISSUES, SO WE WENT TO 1:2 BECAUSE WHEN WE¿RE IN 1:1, IT ALMOST WENT FLAT, AN IMAGE OF THE CONSOLE SCREEN SHOWED THE PUMP IN 1:2 WITH ASSISTED PRESSURES OF 88/49 (69), UNASSISTED 95/52, AND AN AUGMENTATION OF 93. 2 UBEDS WERE PRESENT IN THE IMAGE AS WELL. ALL THE WAVEFORMS APPEARED STABLE, CONSISTENT, AND WITH NO ARTIFACT, PRESSURES OF 85/49 (71), AND AN AUGMENTATION OF 86. IN SHARED IMAGES TROUBLESHOOTING INCLUDED REPLACING THE ELECTRODES, FLUSHING THE INNER LUMEN WITH THE PUMP IN STANDBY, AND VERIFYING PLACEMENT VIA THE MOST RECENT X-RAY IMPRESSION. AFTER LEAD REPLACEMENT AND FLUSHING, THE NUMBERS AND WAVEFORMS WERE LIKE THE BEGINNING OF THE CALL. THE MOST RECENT X-RAY WAS SATISFACTORY PER THE CARDIOLOGIST, AS THE CATHETER HAD BEEN REPOSITIONED AFTER THE MORNING CHEST X-RAY. I REINFORCED OUR RECOMMENDATIONS FOR PLACEMENT, BETWEEN THE 2ND AND 3RD INTERCOSTAL SPACE. CUSTOMER REVIEWED THE IMAGE AND STATED IT LOOKED LIKE IT WAS AT THE 3RD INTERCOSTAL BUT THAT SHE WOULD NOTIFY THE CARDIOLOGIST OF OUR RECOMMENDATIONS. FURTHER DATA COLLECTION DETERMINED THE PATIENT WAS ON SEVERAL IV INFUSIONS, INCLUDING FENTANYL, HEPARIN, HIGH DOSE LEVOPHED, DOPAMINE, AMIODARONE, PROPOFOL, INSULIN, AND NIMBEX. SHE WAS UNAWARE OF THE PATIENT¿S EF, CO, OR SVR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46493 CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male IAB