MAUDE Adverse Event Report: LivaNova Deutschland SCPC; Console, Heart-Lung Machine, Cardiopulmonary Bypass

Model Number	ASY EMRGCY DRV UNT W/3 JNT HLD
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that, while a patient was off the ecmo machine and undergoing a ct scan, centrifugal pump main unit¿s control panel suddenly lost power for 15 minutes, causing the centrifugal pump to stop.Normal operation was resumed after connecting the device to ac power.There was no patient injury.
Additional Manufacturer Narrative
A1-a5 patient information was not provided.H11 reportedly, the backup battery¿s charge level was inaccurately displayed; device battery had been replaced in august.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: SCPC
• Common Device Name: Console, Heart-Lung Machine, Cardiopulmonary Bypass
• Manufacturer (Section D): LivaNova Deutschland; lindberghstraße 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LivaNova Deutschland; lindberghstraße 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 50893942
• Report Number: 9611109-2026-90453
• Device Sequence Number: 6001913
• Product Code: DTQ
• UDI-Device Identifier: 04033817901020
• UDI-Public: (01)04033817901020(11)170727
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K011838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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 Model Number: ASY EMRGCY DRV UNT W/3 JNT HLD
• Device Catalogue Number: 60-01-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 07/27/2017
• Patient Sequence Number: 1
• Patient Sex: Unknown