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

Model Number 801763

Device Problem Failure to Run on Battery (1466)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2015

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the perfusion system was not switching over to battery power.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 field service representative (fsr) checked voltage on the battery and verified charging status.Battery voltages were too low and the unit was trying to charge them confirming the complaint.The fsr replaced the batteries and release test completed.The unit operated to mfr specifications and was returned to clinical use.During the laboratory eval, the product surveillance technician (pst) was able to duplicate the reported issue.Batteries measured 11.9 and 12.1 volts direct current (vdc) upon receipt.A 11.4 vdc is typical for a battery that has been discharged.A 13.2 vdc is typical for a battery having a near full charge.Conductance measurements were 12 siemens (s) (failing) for the first battery and 13s (failing) for the second.The 375s is the minimum requirement for conductance.After charging 13 hours, neither of the two batteries properly accepted charging and both failed to meet minimum specifications for conductance.When alternating current (a/c) power was removed from the test platter, it did not switch to battery power as designed.This indicates that both batteries failed to properly accept charging and corroborates the reported complaint.If additional info 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: 4692944
• MDR Text Key: 5646674
• Report Number: 1828100-2015-00275
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2015

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: 03/31/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2015
• Initial Date FDA Received: 04/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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