BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID

    MDR report key: 16701289 · Received April 7, 2023

    Report

    Report Number
    2249723-2023-01826
    Event Type
    Malfunction
    Date Received
    April 7, 2023
    Date of Event
    March 28, 2023
    Report Date
    April 2, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD RESTRICTION ON IAB CATHETER OR TUBING. SOMEONE FROM (B)(6) HAD CONTACTED THE ESP SUPPORT GROUP FOR THE SAME ISSUE, AND DR. (B)(6) WAS ASKING FOR OTHER POSSIBLE CAUSES FOR THE ALARM. HE CONFIRMED THAT THE IAB WAS IN THE CORRECT POSITION VIA X-RAY , NOR WAS THE IAB FOLDED OVER. THERE WAS NO VISIBLE SIGN OF DISCOLORATION IN THE GAS LINE TUBING NO RESTRICTION. HE SAID THE PATIENT WAS NOT MOVING LEG TO RESTRICT THE GAS LUMEN, AND THERE WERE NO OTHER ALARMS NOTED. HE STATED THE IABP WOULD WORK FINE UNTIL IT DID NOT. HE CONFIRMED THAT THE IAB WAS ZEROED, AND WAVEFORMS WERE GOOD WHEN WORKING PROPERLY. HE LEVEL WAS GOOD. I SUGGESTED SWAPPING OUT IABP'S WHICH WAS DONE, THEN HE INFORMED ME VIA TEXT, NOTHING WORKED, AND THE IAB WAS PULLED. THE IAB WAS NOT SAVED. NO HARM TO PATIENT WAS INDICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DOCTOR INTERVENTIONIST, HACKENSACK MEDICAL CENTER, CONTACTED ABOUT A PATIENT THEY RECEIVED FROM ST. BARNABAS MED CTR, LIVINGSTON, NJ. A MEGA, 50CC, IAB WAS FEMORALLY INSERTED, AND WAS GIVING INTERMITTENT CATHETER RESTRICTION LINES. SOMEONE FROM ST. BARNABAS HAD CONTACTED THE ESP SUPPORT GROUP FOR THE SAME ISSUE, AND DOCTOR WAS ASKING FOR OTHER POSSIBLE CAUSES FOR THE ALARM. DOCTOR CONFIRMED THAT THE IAB WAS IN THE THE CORRECT POSITION VIA X-RAY , NOR WAS THE IAB FOLDED OVER. THERE WAS NO VISIBLE SIGN OF DISCOLORATION IN THE GAS LINE TUBING NO RESTRICTION. CUSTOMER STATED THE PATIENT WAS NOT MOVING LEG TO RESTRICT THE GAS LUMEN, AND THERE WERE NO OTHER ALARMS NOTED. CUSTOMER STATED THE IABP WOULD WORK FINE UNTIL IT DID NOT. CONFIRMED THAT THE IAB WAS ZEROED, AND WAVEFORMS WERE GOOD WHEN WORKING PROPERLY.THE LEVEL WAS GOOD. IT WAS SUGGESTED TO SWAP OUT IABP'S WHICH WAS DONE, THEN HE INFORMED ME VIA TEXT, NOTHING WORKED, AND THE IAB WAS PULLED. THE IAB WAS NOT SAVED. THIS REPORT IS FOR THE IABP THAT ALARMED, THE IAB CATHETER USED IN THIS EVENT IS BEING REPORTED SEPARATELY. THERE WAS NO PATIENT HARM REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795889 CARDIOSAVE HYBRID SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown A MEGA, 50CC, IAB WAS FEMORALLY INSERTED.