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

Model Number 3CX*RX25RE

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 06/17/2019

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 prior to cardiopulmonary bypass, during out box, the manifold was missing from the top of reservoir upon opening the new cxrx25re bag.No patient involvement.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.Identification of evaluation codes 10, 11, 3331, 3259, 4307.The evaluation of the returned sample confirmed that the manifold was missing from the unit as well as the purge line not connected and the yellow vent cap missing.A retention sample from the same lot number was obtained and visually inspected, and confirmed that the manifold, purge line and yellow vent cap were all attached to the unit.All capiox units are 100% visually inspected at several points in the production process.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 ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on september 30, 2019.Upon further investigation of the reported event, the following information is new and/or changed: d10 (device availability - added date returned to manufacturer).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information).H3 (device evaluation anticipated by manufacturer - 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.

• Brand Name: CAPIOX RX25 OXYGENATOR EAST
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 9136648
• MDR Text Key: 162528765
• Report Number: 1124841-2019-00271
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450103
• UDI-Public: (01)00699753450103
• 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
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 3CX*RX25RE
• Device Catalogue Number: N/A
• Device Lot Number: WM29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1