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 801188

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The biomedical technician order a replacement epgs and returned the suspect device to the manufacturer for further evaluation.During laboratory evaluation, the product surveillance technician (pst) noted the electronic patient gas system (epgs) did not power on because of a defective generic board, part number: 801514, serial number: (b)(4).The epgs was connected to a system one simulator and central control monitor (ccm), the front indicator light of the epgs did not illuminate and the epgs did not show up on ccm screen.The pst temporarily replaced the generic board with a lab use only generic board and the epgs then operated as designed.Visual inspection of the suspect generic board did not find any anomalies.The unit will be sent to service to be brought to manufacturer's specification prior to being released for clinical use.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

The biomedical technician (bmet) reported that during a two-year preventive maintenance (pm) of the device, the electronic patient gas system (epgs) that was to replace the existing epgs, had no lights, no power, and did not show up on central control monitor (ccm) screen.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.The service repair technician (srt) replaced the electronic patient gas system (epgs) pod assembly.The newly installed unit operated with manufacturer¿s specifications.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

The reported complaint occurred during field service installation of the device.

• 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: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 6001090
• MDR Text Key: 57057110
• Report Number: 1828100-2016-00660
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2016

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: 801188
• Device Catalogue Number: 801188
• Other Device ID Number: 010088679900058811041222200343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2016
• Initial Date FDA Received: 10/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2004
• 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