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

Model Number 801188

Device Problems Partial Blockage (1065); Gas Output Problem (1266); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, that blood coming back from the pt was black.The perfusionist (ccp) checked the liters per minute (lpm) and they still had gases going.A delay of one minute due to trouble-shooting and move the portable oxygen tank.The customer placed in an oxygen (o2) tank to shoot in oxygen to the pt.The device was not changed out.The surgical procedure was completed successfully, and there was no blood loss or no adverse consequences to the pt.The epgs was calibrated successfully during set-up for the procedure.The gas line from the epgs outlet was routed through a mechanical gas flow meter (provided in sys-1), an anesthetic vaporizer, and then to the gas inlet connector of the oxygenator.At the initiation of cpb, the arterial blood was bright red with indication that oxygenation was adequate.The gas flow was set to 3-3.5 i/min and the fio2 was set to about 0.75.Within the first two minutes of cpb, the aorta was cross-clamped and cardioplegia was administered.The perfusionist (ccp) turned on the anesthetic vaporizer to blend into the gas line to the oxygenator after cpb had been initiated for four to five minutes.The arterial blood started to darken and the ccm displayed a gas flow of 3.5 i/min, but the measured fio2 was displayed as "---".The ccp used the manual fio2 knob on the base on sys-1 and increased the knob position to a fio2 of 1.0.The blood continued to darken and the fio2 display on the ccm remained at ---.The ccp had a portable oxygent tank in the room (with an attached tubing) and he removed the gas line from the oxygenator (connected to sys-1) and connected the tubing from the portable oxygen tank directly to the oxygenator.The arterial blood quickly became bright red as oxygenation improved.The ccp estimated the time of desaturation (lower oxygen levels before connection to oxygen tank) was less than 60 seconds.A couple of minutes after the gas line was connected to the oxygen tank, the vaporizer was turned off since the gas line was no longer being directed thru the vaporizer.Shortly after, the fio2 measurement on the ccp again displayed about.75 (as it was prior to the --- and dark blood event).The ccp elected to use the oxygen tank for the gas supply for the remainder of the procedure.The pt was weaned from cpb without issue, when the procedure was completed and the procedure was completed successfully.There was a delay of about one minute when the poor oxygenation occurred and the issue was being troubleshot prior to connection of the portable oxygen tank.There was no loss of blood due to this incident and there was no harm observed or reported.The field service rep travelled to the hosp later in the day on (b)(6) 2014.The sys-1 logs were collected and analyzed the morning of (b)(6).The logs did show that a condition of "o2 sensor and blender disagree" was posted the same time as the vaporizer was started and the arterial blood became dark.This condition can be caused by obstruction in the gas outlet line and this appeared to happen when gas flow was directed thru the anesthetic vaporizer and likely indicates an obstruction in the vaporizer gas path.The ccp was using the mechanical gas flow meter in the gas line, but it was prior to the vaporizer and was indicating a gas flow of 3.0 1/min.The obstruction in the gas line (due to the vaporizer) was likely created a backpressure and gas was likely being vented from the sys near the vaporizer.This would result in less than intended gas getting to the oxygenator.When the vaporizer was turned off, the "o2 sensor and blender disagree" message cleared which indicates the obstruction was relieved.

Manufacturer Narrative

The field service rep (fsr) could not duplicate the reported issue with the fractionated of inspired oxygen (fio2).The software data logs analyzed by technical support, suggest there was an issue with a vaporizer that is inline with the gas output.It is believed there was some type of blockage at the point to the vaporizer.Technical support was able to duplicate the blockage with similar display of "---" on the central control monitor (ccm).The o2 sensor was replaced in the gas assembly during this preventative maintenance (pm).The unit performed to specifications, release test competed and no failures noted.The unit operated to mfr specifications and was returned to clinical use.Per the lab evaluation, the o2 sensor passed calibration when installed into a lab-tested electronic pt gas sys (epgs).The output voltage from the o2 sensor was within specifications.

• Brand Name: TERUMO ADVANCED PERFUSION SYS 1
• Type of Device: APS 1 (EPGS)
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 3919330
• MDR Text Key: 4586125
• Report Number: 1828100-2014-00116
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801188
• Device Catalogue Number: 801188
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2014
• Initial Date FDA Received: 03/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2007
• 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
• Treatment: ANESTHETIC VAPORIZER,; PORTABLE OXYGEN TANK
• Patient Outcome(s): Required Intervention