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

Model Number 3CX*RX25RW

Device Problem Use of Device Problem (1670)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 02/27/2019

Event Type  Injury  

Manufacturer Narrative

Terumo has not received the 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 when more information becomes available.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that the oxygenator failed with levels at 100% and po2 at 52%.It is unknown when this event occurred, whether the product was changed out, or if there was any effect on the patient or results of the surgery.As per the user facility, the oxygen transfer for this case has been poor.They tried to transfer from using the oxygen wall to using oxygen from an oxygen tank/cylinder, however, this did not make a difference.The anesthesiologist had to administer oxygen from the anesthesia machine.

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 march 26, 2019.  upon further investigation of the reported event, the following information is new and/or changed: (identification of event problem and evaluation codes 2692, 11).A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

Additional information was obtained from the user facility.The event occurred during cardiopulmonary bypass, the product was not changed out and the procedure was completed successfully.The user facility stated that a bolus of propofol was administered by anesthesia during the case.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.  a fourth follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.).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 fda in accord with applicable regulations.(b)(4).The actual sample was not returned for evaluation; however, based on the involved product code/lot number combination, the fiber lot number built in the actual sample has been traced back and used to see for any anomaly.The involved fiber lot number was reviewed, tested for its gas transfer performance, and it was confirmed to meet the specifications.Review of device history record and product release decision control sheet of the involved product / lot combination confirmed there was no indication of anomaly in them.As no sample or involved pump record were provided, the definitive root cause cannot be determined.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 fda in accord with applicable regulations.Method code: 10 - testing of actual/suspected device.Results code: 213 - no device problem found.The actual sample was visually inspected upon receipt and was found that some of the fibers had been broken.Due to the broken fibers, a leak was found to occur from the blood phase to the gas phase, which made it impossible for the actual sample to be tested for its gas transfer performance.However, based on the involved product code / lot number combination, the fiber lot number built in the actual sample was traced back and used to see for any anomaly.No anomaly was confirmed in the result of the gas transfer performance test conducted on the product in which the involved fiber lot number had been built.With no pump record available for evaluation, the definitive root cause of this complaint cannot be determined from the available information.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
• MDR Report Key: 8454506
• MDR Text Key: 139958137
• Report Number: 1124841-2019-00081
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450110
• UDI-Public: (01)00699753450110
• Combination Product (y/n): N
• PMA/PMN Number: K153213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 3CX*RX25RW
• Device Catalogue Number: N/A
• Device Lot Number: VK28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROPOFOL
• Patient Outcome(s): Required Intervention
• Patient Weight: 136