MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS 8000 PERFUSION SYSTEM; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS-SARNS 8000

Model Number 16395

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Biomed was testing unit to find out what the problem was, he knew something was wrong with unit because it has been in back room for 2 months.Customer has decided to get the roller pump repaired.Customer not sure when the issue happened.

Event Description

It was reported that during the use of the device for a non-clinical activity, the tongue was broken on the roller pump.There was no patient involvement.

Manufacturer Narrative

This complaint is related to mdr #1828100-2015-00773.Customer product cannot be repaired at this time due to the required part being in quarantine.The pump is currently set aside and not in use, and will be repaired when the part is available.If the component is returned, it is to be retained.

Manufacturer Narrative

The reported complaint was confirmed.The field service representative (fsr) verified the broken tongue and replaced the molded tongue.The unit operated to manufacturer specifications and was returned to clinical use.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 8000 PERFUSION SYSTEM
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS-SARNS 8000
• 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: 5064462
• MDR Text Key: 25343523
• Report Number: 1828100-2015-00772
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Followup,Followup
• Report Date: 06/05/2016

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: Health Professional
• Device Model Number: 16395
• Device Catalogue Number: 16395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/19/2015; 06/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2011
• 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