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 801188

Device Problems Bent (1059); Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).According to the biomed the issue occurred sometime around(b)(6) 2015.The water trap can be replaced by manufacturer trained person although the biomed was certified in 2011 he never recertified in 2014.The epgs which was due to be replaced in 2013, was not replaced as recommended by the manufacturer.Per the field service representative (fsr) he swapped out the epgs and will be sending the unit back to the manufacturer for further evaluation.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the electronic patient gas system (epgs) was not functioning (flow dropped).The device was not changed out as the user facility's biomedical engineer (biomed) discovered the water trap was bent, he installed another water trap and the unit was functioning.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

(b)(4).The reported complaint was confirmed.As per log analysis, no indication of when the issue occurred.The log covers from march 31, 2015 to october 19, 2015.During that time there is no indication of a problem in the log file.The reported bent water trap should only impact the air input gas pressure.The oxygen (o2) sensor manufacturing date is june 1, 2015 and it was within its life span of six months.As per the fsr, the biomed department of medical facility is fully aware of preventive maintenance (pm) schedule and reconditioning schedule of the epgs.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

During laboratory evaluation, no drop in flow occurred during testing.The product surveillance technician (pst) connected the epgs to a system one simulator and central control monitor (ccm), attached oxygen (o2) and air at 50 psi, entered a perfusion screen on the ccm and waited the 15 minute o2 sensor warm-up period.Initiated calibration and calibration passed.The measurement of the direct current (d/c) output voltage from the o2 sensor at 5 liters per minute (lpm) and 100% o2 was 1.65 volts, within the specification of 0.55-2.758 volts.The pst tested the epgs¿s flow through the range of 0.5 to 10 lpm and operated the epgs over a two day period with no drop in flow occurring.

• 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: 5127162
• MDR Text Key: 27848374
• Report Number: 1828100-2015-00846
• 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: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Followup,Followup
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801188
• Device Catalogue Number: 801188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2010
• 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