MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1

Model Number 801074

Device Problem Gas Output Problem (1266)

Patient Problem No Patient Involvement (2645)

Event Date 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) replaced the o2 sensor.The unit operated to the manufacturer's specification.The suspect part was returned to the manufacturer for further evaluation.

Event Description

It was reported that during repair of an electronic patient gas system (epgs) the out of box oxygen (o2) sensor would not go below 35 percentage gas flow.There was no patient involvement.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed that the displayed output of the electronic patient gas system (epgs) would go below 35%.He was unable to duplicate the reported complaint.The epgs was hooked up to a system 1 simulator and a central control monitor (ccm).Air and oxygen (o2) were attached at 50 pounds per square inch (psi), calibration was initiated and passed.The measurement of the direct current (dc) output voltage from the o2 sensor at five liters per minute (l/min) and 100% o2 was 1.98 volts.With flow set to five l/min the o2% was 21%, 22.2% on the ccm, and 21.1% with the external o2 analyzer.The unit operated to the 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.

• Brand Name: ADVANCED PERFUSION SYSTEM 1
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 8043180
• MDR Text Key: 126387741
• Report Number: 1828100-2018-00571
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K163531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 801074
• Device Catalogue Number: 801074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1