MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; APS 1 (EPGS)

Model Number 801188

Device Problem Failure to Calibrate (2440)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2014

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the electronic pt gas system (epgs) would not calibrate, seemed to be intermittent.The device was not changed out, as they used the epgs for the case.The epgs is now out of service awaiting repair.There was no delay, no blood loss, nor adverse consequences to the pt.

Manufacturer Narrative

Eval is in progress, but not yet concluded.The ccp told the user facility's biomedical engineer (biomed) that they kicked the machine, recalibrated and the epgs worked.Per the field service representative (fsr), a third party service organization performs their preventive maintenance (pm) now.The fsr verified the epgs would not calibrate after two attempts.He downloaded the data logs, replaced the epgs with a reconditioned epgs (serial number (b)(4)) and performed a release test.The unit operated to mfr specifications and was returned to clinical use.The suspect device was returned to the mfr for further eval.

• Brand Name: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: APS 1 (EPGS)
• 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: 4366124
• MDR Text Key: 5288404
• Report Number: 1828100-2014-01112
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801188
• Device Catalogue Number: 801188
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: No
• 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