MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 4L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RW40C

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 12/07/2019

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 prime, noted blood leak detected on arterial outlet of oxygenator.The patient having an ascending/hemi arch replacement.Blood loss of no more than 10ml.The product was changed out.The procedure 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 december 23, 2019.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date).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 and device evaluation).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (identification of evaluation codes (10, 4102, 3331, 213, 67).Method code #1: 10 - testing of actual/suspected device.Method code #2: 4102 - testing of device from other 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 with no anomalies noted.It was observed that blood was on the threads of the cardioplegia port.The sample was built into a water circuit and circulated while being pressurized to 1000mmhg for 10 minutes.No leakage was observed.A representative retention sample was reviewed for damage in the area of the arterial outlet and no damage was observed.The retention sample was built into a water circuit and circulated at 1000mmhg without confirming tightness of any caps.A very slow leak formed from the cardioplegia port.The cardioplegia cap was marked and then tightened approximately 45*.After tightening, the retention was circulated at 1000mmhg for 10 minutes with no leaking observed.Root cause was the cap was not tightened sufficiently prior to bypass.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15RWC W/ 4L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 9512020
• MDR Text Key: 191705881
• Report Number: 1124841-2019-00342
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450790
• UDI-Public: (01)00699753450790
• Combination Product (y/n): N
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 3CX*FX15RW40C
• Device Catalogue Number: N/A
• Device Lot Number: XG03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1