BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURGE CASSETTE GEN 2, STERILE, NON QSK

    MDR report key: 24554279 · Received March 9, 2026

    Report

    Report Number
    1220648-2026-04839
    Event Type
    Injury
    Date Received
    March 9, 2026
    Date of Event
    October 3, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012477
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE PRIMING PROBLEM WAS NO PROBLEM SINCE NO DEFECT WAS FOUND IN THE LOGS AND THE PURGE FLOW AND PRESSURE WERE WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 0

    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

    D4: CORRECTED CATALOG NUMBER.

    Additional Manufacturer Narrative · 0

    H6 MEDICAL DEVICE PROBLEM CODE A141102 WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT.

    Description of Event or Problem · 0

    AN IMPELLA 5.5 WAS INSERTED VIA SURGICAL CUTDOWN OF THE RIGHT AXILLARY ARTERY IN A 72-YEAR-OLD FEMALE WHO PRESENTED WITH CARDIOMYOPATHY, HEART FAILURE, AND CARDIOGENIC SHOCK CLASSIFIED AS SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS STAGE E. THE PATIENT WAS RECEIVING INOTROPIC SUPPORT, VASOPRESSORS, AND MECHANICAL VENTILATION FOR RESPIRATORY SUPPORT AT THE TIME OF IMPLANTATION. THE PURGE SOLUTION CONSISTED OF DEXTROSE 5 PERCENT IN WATER WITH 25 MILLIEQUIVALENTS OF SODIUM BICARBONATE. DURING SUPPORT, THE SYSTEM GENERATED PURGE PRESSURE HIGH ALARMS AND PRIMING-RELATED ISSUES ASSOCIATED WITH THE PURGE CASSETTE. HEMODYNAMIC INSTABILITY WAS NOTED IN THE SETTING OF ADVANCED CARDIOGENIC SHOCK; HOWEVER, NO SPECIFIC SIGNS, SYMPTOMS, OR DIRECT PATIENT HARM WERE REPORTED IN ASSOCIATION WITH THE PURGE-RELATED ALERTS. TROUBLESHOOTING WAS PERFORMED PER STANDARD PROTOCOL. DUE TO PERSISTENT PURGE PRESSURE HIGH ALARMS AND INABILITY TO RESOLVE THE PRIMING ISSUE, THE DEVICE WAS REVISED AND REPLACED. PURGE PRESSURE ALARMS AND PRIMING-RELATED ISSUES ARE KNOWN POTENTIAL OCCURRENCES IN MECHANICAL CIRCULATORY SUPPORT SYSTEMS AND MAY BE ASSOCIATED WITH PURGE CASSETTE FUNCTION, DRIVELINE FACTORS, PURGE FLUID DYNAMICS, OR SYSTEM SETUP VARIABLES. THESE CONDITIONS ARE DESCRIBED IN THE INSTRUCTIONS FOR USE AND ARE MANAGED THROUGH ESTABLISHED TROUBLESHOOTING PATHWAYS, INCLUDING CASSETTE EVALUATION AND DEVICE EXCHANGE WHEN INDICATED. BASED ON THE INFORMATION PROVIDED, THERE WERE NO REPORTED CLINICAL SEQUELAE DIRECTLY ATTRIBUTED TO THE PURGE-RELATED CONDITION. THE PATIENT SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90830 PURGE CASSETTE GEN 2, STERILE, NON QSK TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 1969629 00813502012477

    Patients

    Seq Age Sex Outcome Treatment
    1