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

Model Number 6379

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The fsr found the drive motor speed to be at 3740 revolutions per minute (rpm) when the maximum speed should be 3600 +/- 100 rpm.He adjusted the maximum speed to be within specification.The unit operated to the manufacturer¿s specifications.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the drive motor speed went beyond the maximum speed specification.There was no patient involvement.

Manufacturer Narrative

Please disregard the initial emdr submission for this complaint.It has been determined that this complaint is not valid.

• 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: 7285113
• MDR Text Key: 100671842
• Report Number: 1828100-2018-00085
• 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
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

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: Other
• Device Model Number: 6379
• Device Catalogue Number: 6379
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/21/2018
• Supplement Dates Manufacturer Received: 03/16/2018
• Supplement Dates FDA Received: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1