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

Model Number 9437

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The supplier company is using the device to check air bubble detector (abd) units during production.They need a replacement delphin pump.On 11-may-2016 per manufacturer service manager: unfortunately we cannot ship any to the customer at this time.

Event Description

It was reported that during the use of the device for a non-clinical activity, the customer was starting their production line back up and when they went to hook up the delphin pump, it would not function properly.The motor would not start every time, however if the pump was moved, the motor would usually turn back on.There was no patient involvement.

Manufacturer Narrative

The reported complaint was not confirmed.Diligence attempts were unsuccessful to receive the part for evaluation.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 CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5672577
• MDR Text Key: 45881802
• Report Number: 1828100-2016-00366
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2016

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: 9437
• Device Catalogue Number: 9437
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/29/2016
• Initial Date FDA Received: 05/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1