BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURGE CASSETTE, STERILE, NON-QSK

    MDR report key: 24543678 · Received March 9, 2026

    Report

    Report Number
    1220648-2026-04715
    Event Type
    Injury
    Date Received
    March 9, 2026
    Date of Event
    February 11, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A3A. SEX/ A3B. GENDER IS UNKNOWN. A4. WEIGHT OF THE PATIENT IS UNKNOWN. A5. ETHNICITY IS UNKNOWN. A6. RACE IS UNKNOWN. D4. PRIMARY UDI NUMBER IS UNKNOWN. 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

    AFTER EVALUATION, THE COMPLAINT DOES NOT MEET THE CRITERIA FOR MDR REPORTABILITY AS DEFINED BY 21 CFR 803.50. THE ISSUE WILL BE TRACKED AND TRENDED INTERNALLY. A REGULATORY REPORT IS NO LONGER NECESSARY

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED, SPECIFICALLY THE RETURN OF THE DEVICE, AND EVALUATION/ANALYSIS IS CURRENTLY IN PROGRESS. ACCORDINGLY, SECTION D9 HAS BEEN UPDATED TO REFLECT THE DEVICE RECEIPT DATE. SECTION H6 (INVESTIGATION TYPE, FINDINGS, AND CONCLUSION) HAS ALSO BEEN UPDATED TO ALIGN WITH THIS INFORMATION. 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.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE AN IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 62-YEAR-OLD MALE PRESENTING WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK. THE PATIENT¿S PAST MEDICAL HISTORY WAS UNKNOWN AT THE TIME OF PRESENTATION. THE PATIENT WAS CLASSIFIED AS SCAI STAGE E AND WAS CRITICALLY ILL UPON ARRIVAL TO THE CATHETERIZATION LABORATORY. THE PATIENT REQUIRED DEFIBRILLATION IN THE HOSPITAL ENVIRONMENT PRIOR TO STABILIZATION. REPORTED PATIENT EVENTS FOR THE IMPELLA CP INCLUDE ARRHYTHMIA REQUIRING RESUSCITATIVE MEASURES. ADDITIONAL INFORMATION STATES THAT THE GLUCOSE CONCENTRATION OF THE PURGE SOLUTION REMAINED BELOW 5 PERCENT. THE CATHETERIZATION LABORATORY STAFF CONFIRMED APPROPRIATE PUMP POSITIONING AND FUNCTION AT THE TIME OF PLACEMENT. DURING SUPPORT, ALARMS INDICATING PURGE SYSTEM OBSTRUCTION AND PUMP BLOCK WERE REPORTED. NO KINKS WERE IDENTIFIED IN THE PURGE TUBING AND THE PURGE CASSETTE WAS EXCHANGED. NO SPECIFIC DEVICE-RELATED SIGNS OR SYMPTOMS WERE REPORTED AT THE TIME OF EXCHANGE. REPORTED PATIENT EVENTS FOR THE PURGE CASSETTE INCLUDE PURGE CASSETTE EXCHANGE WITH NO SIGNS, SYMPTOMS, OR PATIENT INVOLVEMENT RELATED TO FAILURE TO DETECT PURGE CASSETTE. EXCHANGE OF THE PURGE CASSETTE IS A COMMONLY UTILIZED STEP WHEN EVALUATING PURGE SYSTEM ALARMS DURING MECHANICAL CIRCULATORY SUPPORT. DESPITE THESE INTERVENTIONS, THE PATIENT REMAINED IN SEVERE CARDIOGENIC SHOCK. CARE WAS ULTIMATELY WITHDRAWN AND THE PATIENT EXPIRED. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENTS OCCURRED IN THE SETTING OF CRITICAL ILLNESS AND ADVANCED CARDIOGENIC SHOCK. A COMPREHENSIVE REVIEW OF THE AVAILABLE INFORMATION DID NOT IDENTIFY EVIDENCE SUGGESTING THE IMPELLA CP OR PURGE CASSETTE CONTRIBUTED TO THE REPORTED CLINICAL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603631 PURGE CASSETTE, STERILE, NON-QSK TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 1960612

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown Other