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

Model Number 6382

Device Problems Failure to Sense (1559); Infusion or Flow Problem (2964)

Patient Problem Not Applicable (3189)

Event Date 04/22/2014

Event Type  malfunction  

Event Description

The service repair tech (srt) reported that during preventative maintenance (pm) at the service center, the flow sensor was not reading flow.There was no patient involvement.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.Per the service repair technician (srt), the centrifugal flow sensor is in good shape; however, the flow sensor is not repairable.The device did not meet manufacturer specifications.

• Brand Name: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: APS 1 (HEART LUNG CONSOLE)
• 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: 3896037
• MDR Text Key: 19719028
• Report Number: 1828100-2014-00355
• 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: 04/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 6382
• Device Catalogue Number: 6382
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/24/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2014
• 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