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

Catalog Number 050300000

Device Problems Crack (1135); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 12/08/2016

Event Type  malfunction  

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 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.

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 (b)(4), 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
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola (modena)
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola (modena) 41037 ; IT 41037
• Manufacturer Contact: joan ceasar ; 14401 w 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6241358
• MDR Text Key: 64583132
• Report Number: 9680841-2017-00001
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 08033178104777
• UDI-Public: (01)08033178104777(17)190629(10)1606280020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011835
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2019
• Device Catalogue Number: 050300000
• Device Lot Number: 1606280020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/10/2017
• Device Age: 8 MO
• Date Manufacturer Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1