MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL COBE CARDIOVASCULAR REVOLUTION@ CENTRIFUGAL BLOOD PUMP WITH PC COATING

Model Number PC

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

The event occurred before any patient involvement.The age of the device was calculated as the time elapsed between device sterilization and the date of the event.(b)(4).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) has received a report that, during circuit setup, the blood out connector of the centrifugal pump revolution completely broken off.The event occurred prior to any patient involvement.

Manufacturer Narrative

Sorin group italia manufactures the revolution centrifugal blood pump.The incident occurred in sapporo; japan.Per exemption number e2016005, sorin group italia s.R.L.Is submitting the report for both sorin group italia s.R.L (manufacturer) and livanova usa., inc.(importer).The complained revolution pump was returned to sorin italia for investigation.Inspection of the pump confirmed the outlet connector was completely broken off.The returned unit was investigated for the presence of possible residual mold-in stress that might facilitate the complained break.Our laboratory test did not highlight any residual mold-in stress thus confirming the break was not ascribable to the device manufacturing.Dhr verification did not reveal any relevant information possibly linked with the claimed defect.Livanova believes that the most probable root cause of the break was a mechanical stress during transportation.As the frequency of this type of event is low and the root cause was not ascribable to a device problem, no corrective action will be undertaken.Livanova will keep monitoring the market.

• Brand Name: COBE CARDIOVASCULAR REVOLUTION@ CENTRIFUGAL BLOOD PUMP WITH PC COATING
• Type of Device: CENTRIFUGAL BLOOD PUMP
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 8381471
• MDR Text Key: 137929540
• Report Number: 9680841-2019-00008
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 08033178104791
• UDI-Public: (01)08033178104791(17)211104(10)1811050025
• 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: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2021
• Device Model Number: PC
• Device Catalogue Number: 050300700
• Device Lot Number: 1811050025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/30/2019
• Device Age: 3 MO
• Date Manufacturer Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1