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

Model Number 801074

Device Problems Out-Of-Box Failure (2311); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 11/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is related to mdr #1828100-2015-00939.When troubleshooting for mdr #1828100-2015-00939, the field service representative (fsr) replaced the original o2 sensor with the o2 sensor from this complaint but the issue was not resolved.During the laboratory evaluation the pst turned the two halves about a sixteenth of a turn to fully tighten the halves.Laboratory evaluation is still ongoing for this complaint.

Event Description

During laboratory evaluation, the product surveillance technician (pst) reported that the two halves of the oxygen (o2) sensor were not fully tightened.There was no patient involvement.

Manufacturer Narrative

(b)(4).The reported complaint was confirmed.During the laboratory evaluation, the product surveillance technician (pst) determined the two halves of the oxygen (o2) sensor not being fully tightened caused the o2% output in the electronic patient gas system (epgs) to drop when the o2 sensor was physically agitated.The 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).The pst connected the epgs to oxygen and air, entered a perfusion screen on the ccm.The pst initiated calibration and calibration 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 1.72 volts, within the specification of 0.55-2.758 volts.When the technician physically agitated the o2 sensor, it caused the o2% to drop 8%.He removed the o2 sensor from the epgs and noticed that the two halves of the o2 sensor were not fully tightened.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-ADVANCED PERFUSION SYSTEM 1
• 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: 5277412
• MDR Text Key: 33723336
• Report Number: 1828100-2015-01021
• 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: 02/18/2016

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: 12/23/2015
• Device Model Number: 801074
• Device Catalogue Number: 801074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2015
• Initial Date FDA Received: 12/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2015
• 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