MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 PURGE CASSETTE GEN 2, STERILE, NON QSK; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Catalog Number	2000171
Medical Device Problem Code	Priming Problem (4040)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
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.
Event or Problem Description
The complainant reported the purge cassette was purged twice after an air in purge alarm occurred.After the alarm came back, the cassette was changed.No issue since, and the cassette has been discarded.
Additional Manufacturer Narrative
B5.Clinical narrative updated and h6 health effect - impact code f1905 is no longer applicable for this report.Malfunction was changed to death.
Event or Problem Description
Clinical narrative: an impella cp was inserted via an unknown access site in a 53-year-old male patient for acute myocardial infarction complicated by cardiogenic shock.The patient¿s comorbidities were unknown, and the society for cardiovascular angiography and interventions (scai) shock stage was not reported.During impella cp support, an air in purge alarm was observed.The purge cassette was purged twice in response; however, the alarm recurred.The purge cassette was subsequently replaced, after which no further issues were reported and impella support continued without additional alarms.The patient expired while on impella cp support.The death is being conservatively reported; however, not related to the purge concerns due to the fact that support was never interrupted.Based on the available information, the outcome is more likely attributable to the patient¿s underlying acute myocardial infarction and cardiogenic shock.
Additional Manufacturer Narrative
D6a and d6b implant and explant dates were reported on the initial report that was submitted and should of been left blank as purge cassettes are not implantable devices.E4 selection was added as it was omitted from the initial report that was submitted.G1 manufacturer site zip code was reported on the initial report that was submitted and should not have been.This code was moved to the correct manufacturer site postal code field.Manufacturer site fax number was added as it was omitted from the initial report that was submitted.H6 component code, type of investigation, investigation findings, and investigation conclusions were updated accordingly based on investigation findings.H11 the impella device was not returned, and the investigation has been completed.Investigation summary - priming problem: the cause of the priming issue was unbale to be determined as no product was returned for investigation.
Additional Manufacturer Narrative
H2 additional information should of been selected along with correction on the previous report that was submitted.

• Brand Name: PURGE CASSETTE GEN 2, STERILE, NON QSK
• 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 (Section G): ABIOMED EUROPE GMBH; neuenhofer weg 3; aachen ; GM
• Manufacturer Contact: derek sammarco ; 22 cherry hill dr.; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24916689
• Report Number: 1220648-2026-06941
• Device Sequence Number: 18604867
• Product Code: OZD
• UDI-Device Identifier: 00813502012477
• UDI-Public: (01)00813502012477(17)281231(10)2050880
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2000171
• Device Lot Number: 2050880
• 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: 04/15/2026
• Supplement Date Received by Manufacturer: 05/15/2026; 06/08/2026; 06/09/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/20/2026; 06/09/2026; 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2026
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 131 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American