MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO PERFUSION SYSTEM 800; 8K

Model Number 16422

Device Problems Failure to Run on Battery (1466); Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/03/2014

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the perfusion system was unplugged and it did not go on battery power.As a result, an alternate device was employed.The surgical procedure was completed successfully.There were no delays, no blood loss, or no adverse consequences to the pt.

Manufacturer Narrative

The customer is going to let the system charge overnight and will call back in the morning if the battery backup still doesn't work.The field service rep (fsr) verified the system ran for thirty minutes on battery power.The fse was unable to verify reported issue.The fsr removed the batteries, as they were due for replacement, and installed new batteries.The fsr verified reference, charge and new battery voltage.The fsr performed a release test and the battery module operated to mfr specs and was returned to clinical use.The reported complaint was not duplicated during lab analysis.Per the lab eval, the suspect batteries were received in a near fully charged condition.The batteries were first charged then passed a load test as described in the instructions for use (ifu).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 800
• Type of Device: 8K
• 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: 3966275
• MDR Text Key: 4611639
• Report Number: 1828100-2014-00523
• Device Sequence Number: 1
• Product Code: DTQ
• 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 Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/03/2014

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: Health Professional
• Device Model Number: 16422
• Device Catalogue Number: 16422
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2014
• Initial Date FDA Received: 06/25/2014
• 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