MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25REC W/RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25REC

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/14/2016

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the device for evaluation; however, 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, the luer lock connections on the top of the reservoir would not lock appropriately.No known impact or consequence to patient.Product was not changed out.Procedure was completed successfully.

Manufacturer Narrative

(b)(4).Method code #1: actual device evaluated.Method code #2: visual inspection.Method code #3: manufacturing review.Results code: non-functional defect.Conclusions code: use error caused or contributed to event.The sample was returned for evaluation.A review of the device history record revealed no manufacturing anomalies.Evaluation of the returned sample confirmed that the luer was not able to lock around the threads on the reservoir port.When the design of the 3cx reservoir lid was compared against the design of the (b)(4) product, or 1cx reservoir, it was found that the wall thickness of the ports differed.The wall thickness of the wall opposite of the threads on the ports is thicker on the (b)(4) reservoir ports.This thicker wall helps keep the threads of the port and luer engaged.The luered ports on the reservoir lid are checked in process for iso 594-1, the internal sealing taper, using a calibrated luer gauge.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: STERILE FX25REC W/RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball rd; elkton MD 21921
• Manufacturer Contact: shari bailey ; 125 blue ball rd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6004660
• MDR Text Key: 56808610
• Report Number: 1124841-2016-00349
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2016

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: 03/31/2019
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: UE11
• Other Device ID Number: (01)00699753450820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2016
• Initial Date FDA Received: 10/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1