MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. REVOLUTION CENTRIFUGAL BLOOD PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Catalog Number	050300000
Medical Device Problem Codes	Crack (1135); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Sorin group (b)(4) manufactures the revolution centrifugal blood pump.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The damaged device has been requested for return to sorin group (b)(4) for investigation.A follow-up report will be sent when the investigation is completed.
Event or Problem Description
Sorin group (b)(6) received a report that the port of the revolution centrifugal blood pump cracked when the perfusionist attempted to attach the tubing to the centrifugal head outlet during priming.The unit was swapped out for the procedure.There was no patient involvement.
Additional Manufacturer Narrative
Device was not returned for investigation.(b)(4).Sorin group (b)(4) manufactures the revolution centrifugal blood pump.The incident occurred in (b)(6).Per exemption number e2016005, sorin group (b)(4) is submitting the report for both sorin (b)(4) (manufacturer) and (b)(4) (importer).Though the involved device was initially thought to be available for return, this was not the case.Therefore, the issue was evaluated based on previously investigated cases for similar issues.Based on these investigations, sorin group (b)(4) believes that the crack may be ascribed to rough handling during transportation, in combination with residual material stress from processing operations.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The product was released in compliance with the specifications.Device not available for return.

• Brand Name: REVOLUTION CENTRIFUGAL BLOOD PUMP
• Common Device Name: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola (modena)
• MDR Report Key: 6241358
• Report Number: 9680841-2017-00001
• Device Sequence Number: 784182
• Product Code: KFM
• UDI-Device Identifier: 08033178104777
• UDI-Public: (01)08033178104777(17)190629(10)1606280020
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K011835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2017

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 Expiration Date: 06/29/2019
• Device Catalogue Number: 050300000
• Device Lot Number: 1606280020
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/10/2017
• Device Age: 8 MO
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2017
• Supplement Report FDA Received Date: 04/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1