MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 E/P-PACK; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	28-98-00
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the s5 e/p-pack.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A livanova service representative was dispatched to the facility to investigate.The service representative replaced the complete e/p-pack.The faulty device has been requested for return to livanova (b)(4) for further investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The investigation is ongoing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Not returned to manufacturer.
Event or Problem Description
Livanova (b)(4) received a report that the user was unable to change the pump set-up of the s5 system during maintenance.The system was powered off and back on and all indications were shown in english and nothing was displayed on the system panel.There was no patient involvement.
Additional Manufacturer Narrative
Livanova (b)(4) manufactures the s5 e/p-pack.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).According to inspector the reported issue could be reproduced and confirmed and was caused by a can-bus time out.This again was caused by a defect in the socket no.7, where the pumps and the system panel are connected.The e/p-pack was repaired and tested for performance.A successful technical safety inspection and the device have been returned to the customer.

• Brand Name: S5 E/P-PACK
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• MDR Report Key: 6425036
• Report Number: 9611109-2017-00217
• Device Sequence Number: 10991944
• Product Code: DTQ
• UDI-Device Identifier: 04033817900832
• UDI-Public: 010403381790083211161216
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2017

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: 28-98-00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/24/2017
• Supplement Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 03/22/2017
• Supplement Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1