MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. CAPIOX RX25 OXYGENATOR WEST; BLOOD GAS OXYGENATOR

Model Number 3CX*RX25RW

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Injury (2348); Blood Loss (2597)

Event Date 12/13/2016

Event Type  Injury  

Manufacturer Narrative

Terumo has not received the actual device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and more information becomes available.(b)(4).

Event Description

The user facility reported to terumo cardiovascular systems that during cardiopulmonary bypass procedure, the patient's oxygen was significantly down and carbon dioxide was significantly up.The patient was a large male, (b)(6).He was diagnosed with an ascending thoracic aneurysm in the er on a (b)(6) and had emergent cardiac surgery in which they replaced the ascending aorta and aortic valve.The procedure had to be re-done the next monday.Approximately 35-40 minutes on cpb there was a sudden increase in pco2 from ~40-45 to 83 mmhg as noted on the cdi 500 monitor.Carbon dioxide was being used at the sterile field which was running at 6 lpm and the nurse was told to decrease it to 3 lpm.The sweep gas was increased from ~ 4.5 lpm to 10 lpm to get the pco2 to decrease back to normal levels.The patient was cooled to 26°c.The patient¿s lactic acid was 18 going into the surgery on monday, normal lactic acid values are 0.5-2.2 mmol/l.The patient¿s bicarbonate level was ~19, an amp of bicarb was administered which resulted in an increase in pco2 values (the hco3- in nahco3 is potentially a big problem since it can be the source of large amounts of co2 according to [h+] + [hco3-] co2 + h2o.The degree of alkalization resulting from increased hc03- is limited by the rise in pco2).The blood flow was increased but that did not help to decrease the pco2 but then realized that the increase in flow would likely not improve co2 removal.It was anticipated that the po2 values would likely start to decrease upon re-warming the patient, an oxygenator change out was prepared.As soon as the patient started to rewarm, the po2 started decreasing.The surgeon was told that the oxygenator was not failing but the patient¿s physiologic conditions were affecting the oxygenator¿s ability to adequately meet the metabolic demands of the device.Another rx25 unit was primed and the change out the of oxygenator was successful.They were off of cpb ~3 minutes.The patient was very fluid overloaded coming into the second surgery.Over 5 liters of fluid was removed with the hemoconcentrator and still had 2.5 liters in the reservoir.The patient received two units of blood after hemoconcentrating; near the end of cpb despite a hematocrit of ~27%.Both acts and hepcon were monitored and both the acts and heparin levels were more than adequate.Although, these values were adequate, the metabolic phenomena going on with this patient could have been affecting the adequacy of anticoagulation.Albumin was added to the pump prime for this case.Product was changed out.Delay for approximately 3 minutes.Estimated blood loss of 150 cc.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on january 9, 2017.A second follow-up will be submitted upon completion of the investigation and/or submission of new information.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Manufacturer Narrative

This follow-up report is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular system in the initial report submitted.(b)(4).The sample was returned for evaluation.A review of the device history record revealed no manufacturing anomalies.The sample was forwarded to (b)(6) for investigation.Visual inspection of the sample did not find any anomalies.The sample was tested for its gas transfer performance.Bovine blood was arranged to (hb12.0g/dl, temp at 37c, ph:7.4, svo2:65% and pvco2:45mmhg) and was circulated under the following conditions: at v/q=1, fio2=100% and the flow rate of 6l/min and 4l/min.Results: o2 transfer: at 6l/min=391ml/min.At 4l/min=280ml/min.Co2 removal: at 6l/min=317ml/min.At 4l/min=231ml/min.No anomalies were noted with the gas transfer performance, the obtained values met factory specifications.A definitive root cause could not be determined; therefore, this complaint is not confirmed.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: CAPIOX RX25 OXYGENATOR WEST
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6233597
• MDR Text Key: 64187936
• Report Number: 1124841-2017-00002
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 3CX*RX25RW
• Device Catalogue Number: N/A
• Device Lot Number: UK22
• Other Device ID Number: (01)00699753450110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other