MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS CENTRIFUGAL SYSTEM; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM

Model Number 164267

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

After use of the device for a cardiopulmonary bypass (cpb) procedure, the unit had a separated connector port.There were no reported adverse consequences to the patient.

Manufacturer Narrative

The field service representative (fsr) verified the broken motor port.He installed a loaner motor.The unit operated to the manufacturer's specifications.The suspect device was returned to the manufacturer for further evaluation.

Manufacturer Narrative

Device was repaired and returned.The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed that the centrifugal drive motor to have an unfastened cover and a broken shield wire.Functional testing was performed and observed the unit to function as intended.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: SARNS CENTRIFUGAL SYSTEM
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 7455875
• MDR Text Key: 106604378
• Report Number: 1828100-2018-00203
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K950739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 164267
• Device Catalogue Number: 164267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1