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

Model Number 801763

Device Problems Bent (1059); Device Stops Intermittently (1599)

Patient Problem Not Applicable (3189)

Event Date 04/08/2014

Event Type  malfunction  

Event Description

The field service representative (fsr) reported that during preventative maintenance (pm) of the device, the power cable of the perfusion system had a pin that was bent.This unit would work intermittently with the bent pin.Since the event occurred during preventative maintenance, there was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed by the field service representative (fsr).The fsr could not bend the pin back in the power cable.The fsr replaced the power cable and completed the preventative maintenance (pm).System-1 and pumps met manufacturer's specifications before being returned to clinical use.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• 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: 3900176
• MDR Text Key: 4648733
• Report Number: 1828100-2014-00322
• 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: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• 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?: Yes
• Date Returned to Manufacturer: 04/16/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2005
• 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