MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM CORP TERUMO PERFUSION SYSTEM 8000; 8K (ROLLER PUMP)

Model Number 16402

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem Not Applicable (3189)

Event Date 01/23/2014

Event Type  malfunction  

Event Description

The field service rep (fsr) reported that during preventative maintenance (pm) of the device, he discovered a broken tongue on roller pump.Since the event occurred during preventative maintenance, there was no pt involvement.

Manufacturer Narrative

The field service rep (fsr) replaced the tongue and drag insert on the roller pump, and completed corrective maintenance.Preventative maintenance (pm) was performed and the unit operated to manufacturer specifications and was returned to clinical use.The suspect roller pump was returned to the manufacturer for further eval.If additional info becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: TERUMO PERFUSION SYSTEM 8000
• Type of Device: 8K (ROLLER PUMP)
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEM CORP; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7345634145
• MDR Report Key: 3756422
• MDR Text Key: 4466987
• Report Number: 1828100-2014-00057
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2014
• 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?: Yes
• Date Returned to Manufacturer: 02/07/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2014
• 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