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 05/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The field service representative (fsr) could not verify the reported issue.The system-1 (aps1) switched to battery power when unplugged.Further troubleshooting found that the battery cable leads were not properly secure onto the battery terminals.The batteries which were installed (b)(6) 2016 were not sourced from the manufacturer.The fsr replaced the batteries and checked system base operation.The aps1 properly switched to battery power when tested.The unit operated to manufacturer specifications and was returned to clinical use.The suspect batteries will be returned to the manufacturer for further evaluation.

Event Description

After use of the device for a cardiopulmonary bypass procedure, the user reported the perfusion system was unplugged and unit died.The system battery will not hold a charge.The unit was removed from service and waiting for repair.There were no reported adverse consequences to the patient.

Manufacturer Narrative

(b)(4).The field service representative (fsr) confirmed that the customer was aware that the in-house biomedical engineer (biomed) installed the batteries.The user facility uses this system regularly so the system batteries should remain charged.The suspect batteries were returned to the manufacturer for further evaluation.During the laboratory evaluation, the reported complaint was not duplicated.The batteries were received in near fully-charged condition.Both batteries accepted charging and were within specification for voltage and conductance.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: 5678204
• MDR Text Key: 45871889
• Report Number: 1828100-2016-00370
• 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: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2016

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: 06/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/03/2016
• Initial Date FDA Received: 05/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2008
• 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