MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION HOLLOW FIBER OXY WITH 3000 ML; BLOOD GAS OXYGENATOR

Model Number 3CX*RX15RE30

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 10/14/2020

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 setup, the oxygenator has a crack at the base of the reservoir.No patient involvement.The product was changed out.The surgery was completed successfully.

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 november 4,, 2020.Upon further investigation of the reported event, the following information is new and / or changed: d1: (added brand name).D4: (additional device information - added udi number, model number and serial number).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.

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: d2 (suspect medical device - added common device name and device product code).D4 (additional device information - added expiration date).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (identification of evaluation codes 10, 11, 3331, 213, 67).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 213 - no device problem found.Conclusions code: 67 - no problem detected.The affected sample was inspected upon receipt to show no visual anomalies.The oxygenator and reservoir were subjected to pressurization to expose potential leakage on the devices.The oxygenator was circulated with water at a pressure of 1000mmhg for approximately 10 minutes with no leakage observed.The oxygenator heat exchanger was filled with water and pressurized to 1500mmhg for approximately 10 minutes with no leakage observed.The reservoir, with all ports blocked off, pressurized to 150mmhg for approximately 10 minutes with no leakage observed.The reservoir was circulated with the circulation stopped periodically to ensure that the venous inlet o-ring was properly seated.No loss of prime or air entrainment was observed at the venous inlet.A representative retention sample was setup for water circulation with the oxygenator pressurized to 1000mmhg.No leakage was observed from the oxygenator.The reservoir was circulated with the circulation stopped periodically to ensure that the venous inlet o-ring was properly seated.No loss of prime or air entrainment was observed at the venous inlet.The oxygenator heat exchanger was filled with water and pressurized to 1500mmhg for approximately 10 minutes with no leakage observed.The described event was not able to be replicated.Therefore, this event is not confirmed.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: HOLLOW FIBER OXY WITH 3000 ML
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 10784183
• MDR Text Key: 216392298
• Report Number: 1124841-2020-00255
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 3CX*RX15RE30
• Device Catalogue Number: N/A
• Device Lot Number: YH13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 11/04/2020; 12/11/2020
• Supplement Dates FDA Received: 11/24/2020; 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1