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 07/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is related to emdr #1828100-2016-00529.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 with fsr on 14-jul-2016: the aps1's front panel indicator light was solid green upon boot-up.The batteries were measured at a correct full voltage reading of 26.6 volts direct current (vdc).The battery capacity in the service menu showed 17.9 amp hours (ah).If the system shuts down completely with all these correct readings then the batteries are failing to carry the load needed to keep the aps1 running.The fsr installed new batteries and the aps1 was able to switch to battery power.He tested battery switching system and charging for extended period of time and reset the battery gauge to full in the service menu.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 complaint was corroborated.One of the two batteries fails the conductance requirement and the other is near failing.This indicates that some level of internal battery degradation has occurred.Also, the batteries had a third party vendor label indicating they were not purchased through the manufacturer.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.There was no patient involvement.

Manufacturer Narrative

The field service representative (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.

• 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: 5843409
• MDR Text Key: 51370562
• Report Number: 1828100-2016-00530
• 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: 10/29/2003
• 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