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); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2015

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, when the perfusion system was unplugged from alternating current (a/c) power, the unit went dead.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the pt.

Manufacturer Narrative

The reported complaint was confirmed.Per the user facility's biomedical engineer (biomed), when the system was unplugged, there was four minutes displayed on the central control monitor (ccm) battery icon and the icon was red.This system has not been used since 04/16/2015 and was not plugged into a/c during that time.The biomed plugged in the unit to charge over the weekend.The fsr arrived on 06/08/2015 and the unit was fully charged and operated on battery back-up.The fsr replaced the batteries that were delivered to the customer.The unit operated to mfr specifications and was returned to clinical use.The suspect batteries were returned to the mfr for further eval.During the laboratory eval, the reported issue was not duplicated.The product surveillance technician (pst) observed both batteries to exceed the minimum specifications for characteristics evaluated.No anomalies were observed upon receipt of the batteries.Batteries measured 13.2 and 13.1 volts direct current (vdc) upon receipt (13.2 vdc is typical for a battery having a near full charge).Conductance measurements were 451 siemens (s) for both batteries (375s is the minimum requirement of conductance).Batteries were found to be fully recharged after only three hours (recommended recharging from full depletion is 13 hours).Total nominal available capacity (tnac) is 18 amp hours (ah), indicates full charge.After charging, the voltage and conductance readings of both batteries were: 13.4v/458s.This indicates that both batteries properly accept charging.If additional info becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

The reported complaint was confirmed.Data log analysis showed the monitor was left shut down for a month and a half without charging which caused the depleted batteries.No additional action will be taken at this time.

• 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: 4874052
• MDR Text Key: 17215821
• Report Number: 1828100-2015-00505
• 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: Health Professional,User Facility,health professional,use
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/28/2015

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: Health Professional
• Device Model Number: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2015
• Initial Date FDA Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-03/13/12-004-C
• Patient Sequence Number: 1