MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 PURGE CASSETTE, PACKAGED; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Catalog Number	0043-0002
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's height and weight not provided.
Event or Problem Description
The complainant reported a patient noted as high risk percutaneous coronary intervention was implanted with an impella device for mechanical circulatory support.   cassettes did not register when put into the controller.The purge cassette was changed twice and the third purge cassette was recognized by the controller.The case was completed and the patient did very well.No patient harm was reported due to the issue.
Additional Manufacturer Narrative
Section d medical device has been updated.
Additional Manufacturer Narrative
Corrected information were provided in d3 and g1.Upon review, it was identified that these were inadvertently omitted from the initial report.H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.The current (b)(4) is open to address the failure to detect purge cassette issue involving the first purge cassette, s/n (b)(6), lot 1926169.Data log review was not sufficient to derive the cause of the purge cassette not detected issue.The cause of the failure to detect purge cassette issue could not be determined without the returned product for investigation and sufficient clinical details.

• Brand Name: PURGE CASSETTE, PACKAGED
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24539890
• Report Number: 1220648-2026-04659
• Device Sequence Number: 13018513
• Product Code: OZD
• UDI-Device Identifier: 00813502010510
• UDI-Public: (01)00813502010510(17)261031(10)1813686
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0043-0002
• Device Lot Number: 1813686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 03/23/2026; 05/12/2026
• Initial Report FDA Received Date: 03/07/2026
• Supplement Report FDA Received Date: 03/24/2026; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White