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

Model Number PC

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

The age of the device was calculated as the time elapsed between device sterilization and the date of the event.(b)(4).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The involved device has been requested for return to sorin group (b)(4) for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Sorin group (b)(4) received a report that a loud grinding noise was heard coming from the revolution centrifugal blood pump and the flow being delivered to the patient became inadequate during a procedure.The user was unable to reestablish adequate flow and the centrifugal pump was removed and a roller pump was utilized for the remainder of the case.The patient reportedly experienced low arterial pressure for about 4 minutes.There was no report of patient injury.

Manufacturer Narrative

Sorin group (b)(4) manufactures the cobe revolution centrifugal blood pump with pc.The incident occurred in (b)(4).Per exemption number e2016005, (b)(4).The involved device was returned to sorin group (b)(4) for investigation.Visual inspection was unable to identify any defects.Simulated use testing was conducted and the device was found to emit an abnormal noise as the pump rotation was increased.However, this did not affect the performance of the device and the unit was able to deliver flow according to specification.As the flow issue could not be reproduced, a root cause was not identified.A possible cause of the noise could be internal mechanical damage to the hub or the impeller caused by rough handling, leading to anomalous rotation.

• Brand Name: COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC
• 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) 41037 ; IT 41037
• MDR Report Key: 7111812
• MDR Text Key: 95767904
• Report Number: 9680841-2017-00033
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 08033178104791
• UDI-Public: (01)08033178104791(17)200829(10)1708310020
• Combination Product (y/n): N
• PMA/PMN Number: K030462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2020
• Device Model Number: PC
• Device Catalogue Number: 050300700
• Device Lot Number: 1708310020
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/30/2018
• Device Age: 3 MO
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 01/30/2018
• Supplement Dates FDA Received: 02/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1