BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 24638785 · Received March 19, 2026

    Report

    Report Number
    1220648-2026-05624
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    March 12, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION RECEIVED AND TO DOCUMENT THAT THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE PATIENT SURVIVED THE IMPELLA CP EXPLANT. SECTION D9 HAS BEEN UPDATED TO REFLECT THAT THE PRODUCT WAS RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT DURING ONGOING SUPPORT WITH AN IMPELLA CP, A ¿PLACEMENT SIGNAL LOW¿ ALARM WAS INTERMITTENTLY OBSERVED ON (B)(6) 2026 AND AGAIN ON (B)(6) 2026. THE PLACEMENT SIGNAL WAS REPORTED TO FLUCTUATE BETWEEN VALUES CONSIDERED NORMAL AND ARTIFACT. INITIALLY, THE AORTIC (AO) PRESSURE WAVEFORM CORRELATED WITH THE ARTERIAL LINE; HOWEVER, THE AO WAVEFORM LATER NO LONGER CORRELATED WITH THE ARTERIAL LINE. PUMP POSITION WAS ASSESSED AND CONFIRMED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND X-RAY, AND THE PUMP WAS DETERMINED TO BE APPROPRIATELY POSITIONED. AN ATTEMPT WAS MADE TO REPOSITION THE PUMP; HOWEVER, NO CHANGE TO THE ALARM BEHAVIOR WAS OBSERVED. A DECISION WAS MADE BY THE CLINICAL TEAM TO DISABLE THE PLACEMENT SIGNAL ALARM AND CONTINUE TO MONITOR MOTOR CURRENT, PUMP SETTINGS, AND PATIENT HEMODYNAMICS. AN ATTEMPT WAS MADE TO ENTER FLOW MODE (FM); HOWEVER, THE SYSTEM DID NOT ALLOW THIS ACTION, INDICATING THAT THE CONDITION WAS RELATED TO PUMP POSITIONING. ADDITIONALLY, THE COMPLAINANT REPORTED THAT ON (B)(6) 2026, DURING SUPPORT WITH THE SAME IMPELLA CP, A ¿PURGE PRESSURE LOW¿ ALARM WAS OBSERVED. NO LOOSE CONNECTIONS WERE IDENTIFIED. THE ALARM RESOLVED WITHOUT INTERVENTION. AS A PRECAUTION, THE PURGE SYSTEM WAS DE-AIRED. A DISCUSSION OCCURRED REGARDING REPLACEMENT OF THE PURGE CASSETTE SHOULD THE ALARM RECUR. NO FURTHER PURGE-RELATED ISSUES WERE REPORTED AT THE TIME OF DOCUMENTATION. AT THE TIME OF REPORTING, THE PATIENT REMAINED ON IMPELLA CP SUPPORT. NO SIGNS OR SYMPTOMS OF PATIENT INJURY WERE REPORTED, AND NO PATIENT HARM WAS REPORTED IN ASSOCIATION WITH THIS EVENT. THIS COMPLAINT INVOLVES TWO IMPELLA DEVICES: IMPELLA CP, WITH SERIAL NUMBER (B)(6). IMPELLA PURGE CASSETTE, WITH LOT NUMBER 2041974 THIS MDR SPECIFICALLY ADDRESSES IMPELLA CP, WITH SERIAL NUMBER (B)(6), WHICH IS THE SUBJECT OF THIS REPORT. SEPARATE MDRS WILL BE SUBMITTED FOR OTHER DEVICES ASSOCIATED WITH THIS COMPLAINT, AS APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700268 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027843476 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male