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

Model Number 801074

Device Problems Incorrect Measurement (1383); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 01/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint is confirmed.The defective oxygen (o2) sensor was evaluated by product quality assurance (pqa) department and the complaint condition was duplicated.The o2 sensor passed voltage but failed o2 reading accuracy.The o2 sensor was sent to the supplier for furhter analysis.

Event Description

Upon receipt of the device, the service repair technician (srt) reported that there was a failure during oxygen (o2) sensor accuracy testing in which the o2 sensor was causing inaccurate readings.The srt replaced the o2 sensor with new one and the unit operated to manufacturer specifications and was returned to clinical use.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.The supplier provided a summary report regarding the sensor failure issues.Test results for the oxygen (o2) sensor show that it passed the supplier's evaluation.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: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5402693
• MDR Text Key: 37625135
• Report Number: 1828100-2016-00050
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2016

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: Other
• Device Expiration Date: 03/23/2016
• Device Model Number: 801074
• Device Catalogue Number: 801074
• Device Lot Number: 12578-108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2016
• Initial Date FDA Received: 02/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2015
• 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