MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1

Model Number 801763

Device Problem Failure to Run on Battery (1466)

Patient Problem No Patient Involvement (2645)

Event Date 04/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The ccp used and has been using the system-1 plugged into alternating current (a/c) power.Per follow-up with the ccp: there was zero minutes displayed on the central control monitor (ccm) battery icon when it was unplugged; there was zero lag time between unplugged and shut down; the light on the power manager board (pmb) was green indicating a fully charged battery back-up; no audible or visual warning was observed before the system shut down; the unit is plugged in at all times; they system is charged at least once a month; they do not fully discharge the batteries.

Event Description

It was reported that during the use of the device for a non-clinical activity (to move unit into the operating room), when the perfusionist (ccp) unplugged the system-1 (aps1), it shut off and did not go to battery back-up.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.The field service representative (fsr) verified that the system-1 was having battery issues and that the system powered off when unplugged.After removing the suspected bad batteries, the fsr measured the voltage across the terminals and each battery was reading approximately 8 volts direct current (vdc).The fsr replaced the batteries, performed preventive maintenance (pm) inspection and all release testing.The unit operated to manufacturer specifications and was returned to clinical use.The suspect batteries were returned to the manufacturer for further evaluation.During the laboratory evaluation, the reported issue was confirmed.Both batteries were received in severely depleted condition, indicating lack of proper maintenance and/or internal battery degradation.No attempt to recharge was made.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: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5666000
• MDR Text Key: 45474676
• Report Number: 1828100-2016-00356
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/19/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2016
• Initial Date FDA Received: 05/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2007
• 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