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 Consequences Or Impact To Patient (2199)

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When the field service representative (fsr) received the phone call from the ccp, the fsr mentioned to the ccp that the unit should be left on a/c for the batteries to charge up.Upon arrival, the fsr found the unit to power up on battery and indicated 247 minutes.The fsr checked the power supplies and batteries, these were found to be within manufacturers specifications.In talking with the ccp, he mentioned that this system is not used on a regular basis.The fsr mentioned the charging process and directed him to the operators manual regarding exercising the batteries.The fsr will return to replace the batteries once they become available.The unit operated to manufacturer specifications and was returned to clinical use.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the system would not power up on battery when unit was unplugged from alternating current (a/c).The device was not changed out, as the perfusionist (ccp) decided to continue on and completed the case without incident.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

(b)(4) - maintenance does not comply to manufacturers recommendations.The reported complaint was confirmed.The field service representative (fsr) replaced the batteries, reset the battery in the service screen and checked operation.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 not duplicated.The suspect batteries met specifications during the evaluation.The batteries measured 12.6 volts direct current (vdc) and 12.5 vdc upon receipt (typical).Conductance measurements were 470 siemens(s) and 435s respectively (passing).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: 5273254
• MDR Text Key: 33380272
• Report Number: 1828100-2015-01015
• 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: 02/12/2016

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: 01/25/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2015
• Initial Date FDA Received: 12/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2010
• 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