MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERUSION SYSTEM 1; APS 1 (HEART LUNG CONSOLE)

Model Number 801074

Device Problems Metal Shedding Debris (1804); Out-Of-Box Failure (2311); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 01/30/2015

Event Type  malfunction  

Event Description

The service repair tech (srt) reported that during electronic patient gas system (epgs) reconditioning, the connector would not seat properly into the oxygen (o2) sensor.This is considered an "out of box" failure.There was no patient involvement.

Manufacturer Narrative

The s.R.T.Replaced the o2 sensor.The epgs is reconditioned per the mfr specifications.The unit operated to mfr specifications and was returned to clinical use.If additional info becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

The reported complaint was confirmed.Inspection of the sensor found that the oxygen (o2) sensor connector does not connect as firmly as the lab sensor and is loose.Visual inspection shows the returned sensor may be missing contacts internally, but when tested this sensor operates to the manufacturer specifications.There is no specification for how tight the sensor should connect to its connector.Measurements of the insert ports appeared to be in line with the other sensors.Examination of the sensor port interior with camera equipment, founds solder deposits inside the cable insert port shaft.This is the cause of the reported insertion issue and would have been deposited during the production process.

• Brand Name: TERUMO ADVANCED PERUSION SYSTEM 1
• Type of Device: APS 1 (HEART LUNG CONSOLE)
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 7346634145
• MDR Report Key: 4550585
• MDR Text Key: 5524763
• Report Number: 1828100-2015-00143
• 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: 01/30/2015

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: 02/07/2015
• Device Model Number: 801074
• Device Catalogue Number: 801074
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2015
• Initial Date FDA Received: 02/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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