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

Model Number 16402

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is related to emdr #1828100-2015-00987.The service repair technician (srt) replaced the indicator dial, performed preventive maintenance (pm) inspection and verification/release test.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.

Event Description

The service repair technician (srt) reported that during routine testing of the device at the service center, the indicator dial silkscreen increment markings are worn off on the roller pump.There was no patient involvement.

• Brand Name: SARNS 8000 PERFUSION SYSTEM
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE - SARNS ROLLER PUMP
• 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: 5584252
• MDR Text Key: 43551438
• Report Number: 1828100-2016-00255
• Device Sequence Number: 1
• Product Code: DWB
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 16402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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