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

Model Number 801763

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

Patient Problem No Patient Involvement (2645)

Event Date 09/12/2014

Event Type  malfunction  

Event Description

The field service representative (fsr) reported that during notice of field correction (nfc) activities, he found the system-1 would not boot-up on battery.The system is a back-up and has not been used or charged in months.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.The field service representative (fsr) replaced the batteries in the system-1.The fsr performed a release test and waited for the power manager to reset to 18.0 ah.The unit operated to manufacturer specifications and was returned to clinical use.The suspect batteries were returned to the manufacturer for further evaluation.Per the laboratory evaluation, the batteries were received in a severely depleted condition, the batteries measured 2.0 and 2.5 vdc.The batteries were installed on (b)(4) 2012.

• 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: 4152476
• MDR Text Key: 4910460
• Report Number: 1828100-2014-00815
• 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: 09/12/2014

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: Other
• Device Model Number: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2014
• Initial Date FDA Received: 10/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2004
• 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