MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM CORP TERUMO ADVANCED PERFUSION SYSTEM 1; APS 1 (HEART LUNG CONSOLE)

Model Number 24710008

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the metal part of the temperature probe was physically cracked.There was no patient involvement.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.The fsr replaced the temperature probe with the customer's spare probe.

• Brand Name: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: APS 1 (HEART LUNG CONSOLE)
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEM CORP; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4375948
• MDR Text Key: 5286404
• Report Number: 1828100-2014-01160
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 24710008
• Device Catalogue Number: 24710008
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/22/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2014
• 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