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

Catalog Number	2000456
Medical Device Problem Codes	Decrease in Pressure (1490); Priming Problem (4040)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
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 was implanted with an impella 5.5 via surgical aorta for mechanical circulatory support."purge system air contamination" and "purge system fluid leak" alternately occurred.The purge set was replaced because it did not improve even though it was according to the control unit's instructions.Then the alarm disappeared completely.No liquid leaks were found from the connecting connector area or from the purge cassette area.
Event or Problem Description
Additional information received: the patient survived the explant.
Additional Manufacturer Narrative
B5 narrative was updated.
Event or Problem Description
Additional information received reporting "two alarms sounded, prompting them to replace the purge set.After the replacement, the issue was resolved." it was also reported that "there were no visible issues with the purge set that was replaced.In summary, although the alarms occurred and the purge set was changed, no external or visible damage was found.".
Additional Manufacturer Narrative
B5.Additional event description added.H6.Medical device problem code added.
Additional Manufacturer Narrative
Added: d3, d6a, d6b priming problem / purge pressure low: the cause of the priming problem and purge alarms "air in purge system" and "purge system open" was not determined due to no product returned, no data logs recovered, and insufficient clinical details.

• 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, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24953334
• Report Number: 1220648-2026-07032
• Device Sequence Number: 10075594
• Product Code: OZD
• UDI-Device Identifier: 00813502012477
• UDI-Public: (01)00813502012477(11)251030(10)2013839
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 2000456
• 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: 04/16/2026
• Supplement Date Received by Manufacturer: 04/24/2026; 05/06/2026; 06/30/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 04/29/2026; 05/11/2026; 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2025
• 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: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian