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

Model Number 3CX*RX25RW

Device Problem Device Issue (2379)

Patient Problem Blood Loss (2597)

Event Date 01/04/2016

Event Type  Injury  

Manufacturer Narrative

Terumo has received the actual device for evaluation; however, 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.For this reason, terumo referenced evaluation conclusion code 11.(b)(4).

Event Description

The user facility reported to terumo cardiovascular systems corporation that during cardiopulmonary bypass they experienced issues while using the rx25 oxygenator.At the initiation of cpb, the arterial blood became dark and appeared to be desaturated.The gas supply to the oxygenator that was being provided by the epgs of the terumo system-1, was adequate per the users' expectations.The calibration of the epgs was successful prior to cpb, and gas flow and fio2 levels were able to be set and adjusted as needed.A mechanical gas flow meter was used and positioned between the epgs outlet and the oxygenator gas inlet and the outputs from the flower matched the flow rate displayed on the ccm.After some troubleshooting of the hardware and other gas supply components, such as the gas line tubing and vaporizer, the clinical team decided to change out the oxygenator prior to cardioplegic arrest of the heart.As the patient's heart was still beating, the patient was ventilated by anesthesia and the patient was weaned from cpb.The patient was weaned with good hemodynamics and remained stable during the change out of the cpb circuit components, the sarns centrifugal pump, terumo af125x arterial filter, and the rx25rw oxygenator with reservoir.The cdi 500 was being used, but not the printer; therefore, any measured blood gas values are not known.There was an estimated blood loss of 600 to 800 ml due to the change out.Once the change out was complete, cpb was re-initiated approximately 55 minutes later.The patient was hemodynamically stable during this time.The total delay due to this event was 60 minutes.There were no other issues the remainder of the procedure, and the case was completed successfully.The patient was weaned from cpb without issue, and was alert and extubated just a few hours after the procedure.No patient harm was observed.The epgs was changed out with a reconditioned unit as a result of this case.

Manufacturer Narrative

This follow-up report is submitted to fda in accordance with applicable regulations - and as indicated by terumo cardiovascular systems corporation in the initial report submitted to the fda on january 21, 2016.(b)(4).The sample was visually inspected upon receipt and no anomalies were noted.A review of the device history records revealed no anomalies.The sample was then tested for its gas transfer performance, no anomalies were revealed and the obtained values met the factory specifications.A definitive root cause could not be determined and the complaint was 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 CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: shari bailey ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 5384276
• MDR Text Key: 36584377
• Report Number: 1124841-2016-00034
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 3CX*RX25RW
• Device Lot Number: TG15
• Other Device ID Number: (01)00699753450110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2015
• 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
• Patient Weight: 127