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

Model Number 16402

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 02/13/2014

Event Type  malfunction  

Event Description

A field service rep (fsr) reported that during customer requested time and material preventative maintenance (pm) of the device, the roller pump lid had a crack near hinge point.The lid did not mount securely to roller head due to worn black plastic mounts.This unit is being used for animal research-"not for human use." since the event occurred during preventative maintenance, there was no pt involvement.

Manufacturer Narrative

Further discussion with the field service rep (fsr), the roller pump lid is very loose, not very secure and could fall off the pump if bumped during use.This would lead to a pump stop.The field service rep (fsr) install a new roller pump lid.The suspect lid was returned to the mfr for eval.If add'l 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 SYSTEMS CORP; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 3832098
• MDR Text Key: 4453412
• Report Number: 1828100-2014-00187
• 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: 02/13/2014

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: 16402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/26/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2014
• Initial Date FDA Received: 03/07/2014
• 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