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 Problems Failure to Run on Battery (1466); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Patient Involvement (2645)

Event Date 07/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is related to emdr #1828100-2016-00530.The reported complaint was confirmed.Per the fsr: the batteries in the aps1 is of the same type and manufacturer, but they did not come from manufacturers stock.The user facility¿s biomedical engineer (biomed) has taken responsibility for their periodic maintenance for the past 12 years after their warranty expired after first being installed back in 2003.A tag on each of the batteries shows a 2012 date.The fsr suspects the batteries are four years old and have lost their ability to carry a ¿load¿ when needed.Per follow-up email with fsr on 14-jul-2016: the aps1's front panel indicator light was solid red upon boot-up.The voltage for the batteries, was almost zero at 4.6 volts direct current (vdc).The battery capacity in the service menu showed 0.0 amp hours (ah).The batteries were dead and could not be charged.The fsr installed new batteries and reset battery gauge to full in the service menu, which resolved the problem.The fsr completed the loading of the new software for aps1 knowing the front indicator light was a steady red, and he would check that out next.All updates and repairs and testing was successfully completed.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 corroborated.Both batteries were received in severely depleted condition, indicating that internal degradation has occurred.No attempt to recharge the batteries was made.The fsr noted that the customer is aware that the batteries need to be replaced every two years.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

It was reported that during the notice of field correction (nfc), the system-1 (aps1) failed and went dead when the field service representative (fsr) pulled the power cord from the wall outlet.This is a back-up unit.There was no patient involvement.

Manufacturer Narrative

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: 5843406
• MDR Text Key: 51370808
• Report Number: 1828100-2016-00529
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2016

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: Other
• Device Model Number: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2016
• Initial Date FDA Received: 08/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2003
• 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