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

Model Number 816300

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The service repair technician (srt) reported that during routine testing of the device at the service center, two pins were pushed in on the power cable for the central control monitor (ccm).There was no patient involvement.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

• Brand Name: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: APS 1 (CCM)
• 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: 4349485
• MDR Text Key: 5180264
• Report Number: 1828100-2014-01074
• 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: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 816300
• Device Catalogue Number: 816300
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/26/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2012
• 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