BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

    MDR report key: 24699845 · Received March 26, 2026

    Report

    Report Number
    1220648-2026-05984
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    March 18, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF TWO RELATED REPORTS. THIS REPORT REPRESENTS THE PURGE CASSETTE AND ANOTHER REPORT WAS SUBMITTED TO REPRESENT THE IMPELLA CP. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    COMPLAINT CODING WAS UPDATED TO MORE ACCURATELY REFLECT THE REPORTED EVENT. THIS UPDATE INCLUDED THE REMOVAL OF THE ¿USE AGAINST LABELING¿ CODE, AS IT WAS NOTED THAT THE CASSETTE IS SUPPLIED WITH A LABEL ATTACHED TO THE TUBING AND THERE ARE NO INSTRUCTIONS IN THE IFU TO REMOVE IT. AS A RESULT, THE H6 HEALTH EFFECT ¿ CLINICAL/IMPACT AND MEDICAL DEVICE PROBLEM CODING HAVE BEEN UPDATED, CORRECTED AND SHOULD BE CONSIDERED THE REPRESENTATION OF THE REPORTED EVENT. THE INVESTIGATION IS STILL UNDERWAY AND ONCE COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: TYPE, FINDINGS, CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION/ANALYSIS OF THE DEVICE WAS NOT POSSIBLE. THE CAUSE OF THE HIGH PURGE PRESSURE ISSUE COULD NOT BE DETERMINED WITHOUT RETURNED CASSETTE INVESTIGATION AND SUFFICIENT CLINICAL DETAILS, INCLUDING DATA LOGS.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: A 48-YEAR-OLD FEMALE SUPPORTED WITH AN IMPELLA CP DEVICE FOR ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, WITH A PRE SUPPORT CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE D, EXPERIENCED A HIGH PURGE PRESSURE/PURGE SYSTEM BLOCKED ALARM ON (B)(6) 2026. THE RN REPORTED PERSISTENTLY ELEVATED PURGE PRESSURES (850¿1000 MMHG). WITH ONGOING ALARMS AND INABILITY TO RESOLVE THE OBSTRUCTION, THE CLINICAL TEAM ELECTED TO PROCEED WITH PUMP REMOVAL IN THE CATHETERIZATION LAB THE SAME EVENING, BASED ON THE AVAILABLE INFORMATION, THE IMPELLA CP DEVICE EXHIBITED PERSISTENTLY HIGH PURGE PRESSURES UNRESPONSIVE TO STANDARD TROUBLESHOOTING AND PURGE CASSETTE REPLACEMENT. THE EVENT NECESSITATED EARLY PUMP EXPLANT, AND THE PRODUCT WILL BE RETURNED FOR ANALYSIS TO DETERMINE THE ROOT CAUSE OF THE PURGE SYSTEM BLOCKAGE. THE PATIENT REMAINED CLINICALLY STABLE AND SURVIVED THE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62443 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648

    Patients

    Seq Age Sex Outcome Treatment
    1