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

Model Number 801074

Device Problems Out-Of-Box Failure (2311); Failure to Calibrate (2440)

Patient Problem No Patient Involvement (2645)

Event Date 04/15/2015

Event Type  malfunction  

Event Description

The field service rep (fsr) reported that during the repairs for mdr #1828100-2015-00363, the oxygen (o2) sensor would not calibrate.The fsr made three attempts to calibrate.Tech support advised the fsr not to use sensor.The fsr installed another o2 sensor and the unit calibrated correctly.There was no pt involvement.

Manufacturer Narrative

This complaint is related to mdr # 1828100-2015-00363.The fsr downloaded the data logs for further eval.During laboratory eval, the lab-tested electronic pt gas system (epgs) passed calibration when the returned o2 sensor was installed.The output voltage from the o2 sensor was within specs.The product surveillance tech (pst) installed the returned o2 sensor into a lab-tested epgs and connected the epgs to a system-1 simulator and central control monitor (ccm).After the 15 minute warm-up period, calibration of the o2 sensor was initiated and passed.Five attempts at calibration were all successful.The measurement of the direct current (d/c) output voltage from the o2 sensor at 5 liters per minute (lpm) and 100% o2 was 1.98 volts which is within the spec of 0.55-2.758 volts.

Manufacturer Narrative

The reported complaint was confirmed.The data logs showed that the oxygen (o2) sensor for the sensor were a little off specified values.Data logs with the new sensor were normal.No add'l action will be taken at this time.

Event Description

Add'l info: per further clarification with the field service rep (fsr), he was able to calibrate the electronic pt gas system (epgs) after third attempt.

• 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 ; 7346634145
• MDR Report Key: 4762819
• MDR Text Key: 5785626
• Report Number: 1828100-2015-00377
• 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,Followup
• Report Date: 04/15/2015

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: 07/24/2015
• Device Model Number: 801074
• Device Catalogue Number: 801074
• Device Lot Number: 11953-024
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/15/2015
• Initial Date FDA Received: 05/07/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/18/2015; 07/15/2015
• 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