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 Problem No Information (3190)

Event Date 01/30/2019

Event Type  malfunction  

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 has oxygenation problems.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.Terumo continues to attempt to gain more information regarding this event from the user facility.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: g4 (date received by manufacturer), g7 (indication that this is a follow-up report), h2 (follow-up due to additional information), h6 (identification of evaluation codes 10, 11, 4114, 33331, 67, 4315).Method code #1: 3331 - analysis of production records, method code #2: 4114 - device not returned, results code: 3221 - no findings available, conclusions code #1: 67 - no problem detected, conclusions code #2: 4315 - cause not established.The actual sample was not returned for evaluation, and lot number was not provided.The fiber lot number produced during the past three years were reviewed for its gas transfer performance, and all results were confirmed to meet the specifications.Without the actual sample or involved pump record, the definitive root cause of this complaint 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.Upon further investigation of the reported event, the following information is new and/or changed: b5 (updated describe event or problem).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information).H6 (identification of event problem and evaluation codes 11).A 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

Per clinical review, 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 ¿ 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: b3 (updated date of event).B5 (updated describe event or problem).E1 (initial reporter - added email address and telephone number).G3 (report source - added distributor).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information).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

As per the user facility, the encountered low oxygenation, flow was not a complete failure.The case proceeded as normal.*the product was not changed out.*the procedure was completed successfully.

• 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: 8454512
• MDR Text Key: 139980560
• Report Number: 1124841-2019-00082
• 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,distri
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/11/2019

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*RX25RW
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1