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

Model Number	28-98-00
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Sorin group (b)(4) manufactures the s5 e/p pack.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).The e/p pack was returned to sorin group (b)(4) for investigation.During functional testing, the reported error was reproduced.Preliminary analysis has identified a faulty wire connection between the hus board and power supply.The wire was repaired and subsequent testing was not able to reproduce the issue.The supplier of the connector has been notified of the issue and the investigation is still ongoing.A follow-up report will be sent when the investigation is complete.Evaluation is on-going.
Event or Problem Description
Sorin group (b)(4) received a report that the s5 e/p pack displayed a ups start-up error during set-up.The customer restarted the unit and the same message appeared.The unit was powered off for a while and could be started normally when powered back on.However, the issue recurred several minutes after restarting the unit.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).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The cause for the loose contact was that pin 2 of the multi-pin connector does not touch both springs of the connector of cable.It was not determined how this defect occurred.This is considered an isolated event.

• Brand Name: S5 E/P PACK
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich,
• MDR Report Key: 6311848
• Report Number: 9611109-2017-00054
• Device Sequence Number: 974921
• Product Code: DTQ
• UDI-Device Identifier: 04033817900832
• UDI-Public: 010403381790083211160803
• 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): 08/29/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Initial Date Received by Manufacturer: 01/18/2017
• Supplement Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 02/08/2017
• Supplement Report FDA Received Date: 08/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1