MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; APS 1 (EPGS)

Model Number 801074

Device Problem Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 05/04/2015

Event Type  malfunction  

Event Description

The svc repair tech (srt) reported that during reconditioning of the electronic pt gas sys (epgs) at the svc ctr, the oxygen (o2) sensor passed calibration, but failed to read within three percent of the analyzer value.This is considered an "out of box" failure.There was no pt involvement.

Manufacturer Narrative

Eval is in progress, but not yet concluded.The srt replaced the o2 sensor in the electronic pt gas sys (epgs).

Manufacturer Narrative

During laboratory evaluation the product surveillance technician (pst) installed the returned oxygen (o2) sensor into a lab-tested electronic patient gas system (epgs) and connected the epgs to a system-1 simulator and central control monitor (ccm).The pst connected the epgs to oxygen and air, entered a perfusion screen on the ccm and waited the 15 minute o2 sensor warm-up period; calibration of the o2 sensor was initiated and passed.The measurement of the direct current (d/c) output voltage from the o2 sensor at 5 liters per minute (l/min) and 100% o2 was 2.22 volts, which is within the specification of 0.55-2.758 volts.The pst measured the o2 output of the epgs at various flows and o2 percentages and oxygen analyzer readings were within specification of ± 3% at different flow rates and o2 settings.Nothing was observed that would cause failure by the pst.

Manufacturer Narrative

The reported complaint was confirmed.As per electronic patient gas system (epgs) product performance specification, the oxygen (o2) sensor output is directly proportional to pressure.The outlet pressure of the gas blender varies with atmospheric pressure, flow rate and circuit restriction.It suggests that there are many factors that can affect the o2 output accuracy.No additional action will be taken at this time.

• Brand Name: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: APS 1 (EPGS)
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4808464
• MDR Text Key: 5893650
• Report Number: 1828100-2015-00463
• 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,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 10/06/2015

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 Expiration Date: 07/03/2015
• Device Model Number: 801074
• Device Catalogue Number: 801074
• Device Lot Number: 12396-072
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/28/2015
• Initial Date Manufacturer Received: 05/04/2015
• Initial Date FDA Received: 05/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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