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

Model Number	3CX*RX25RW
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The user facility reported to terumo cardiovascular that during out of box, the reservoir blood out cap was off and was loose in the tyvek bag.No known impact or consequence to patient.Product not changed out.Procedure completed successfully.
Additional 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.Upon further investigation of the reported event, the following information is new and/or changed: (identification of evaluation codes 4114, 11, 3331, 3259, 4307).Method code #1: 4114 device not returned.Method code #2: 11 testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 analysis of production records.Results code: 3259 improper physical structure.Conclusions code: 4307 cause traced to component failure.The sample was not returned for evaluation, however, a picture was received and reviewed, confirming the blue cap had fallen off of the reservoir outlet.A retention sample from the same product code and lot number combination was inspected and found to still have the blue cap attached.The most likely root cause of the blue cap falling off is due to handling, post shipping, after the tcvs manufacturing process.All reservoirs are 100% visually inspected at several points in the production process.It is likely that the cap fell off due to a shock force at some point during the handling of the product; however, when or how this shock force was applied was not able to be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: CAPIOX RX25 OXYGENATOR WEST
• Common Device Name: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 8565256
• Report Number: 1124841-2019-00114
• Device Sequence Number: 2372716
• Product Code: DTZ
• UDI-Device Identifier: 00699753450110
• UDI-Public: (01)00699753450110
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K153213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 3CX*RX25RW
• Device Catalogue Number: N/A
• Device Lot Number: XA28
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1