MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RWC W/ RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25RWC

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Information (3190)

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 there was no arterial temperature value on the control screen of the console.No other information was provided about the nature of the issue.Terumo continues to attempt to gain more information regarding this event from the user facility.It is unknown when the problem occurred.It is unknown if there was delay in the procedure.It is unknown if the product was changed out.It is unknown if the procedure was completed successfully.It is unknown if there was blood loss.

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 july 19, 2019.Upon further investigation of the reported event, the following information is new and/or changed: a1 (patient information - patient identifier, patient age, date of birth, patient sex and patient weight).B5 (describe event or problem).D4 (additional device information - added exp date).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information).H4 (device manufacture date).H6 (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 affected sample was not returned for evaluation.A representative retention sample from the possible product/lot number combinations were tested and found to be functioning properly.An engineering investigation and capa have been initiated to determine a definitive root cause.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

Additional information was received that the event occurred during cardiopulmonary bypass, there was no delay in the procedure, the product was changed out and the surgery was completed successfully.

• Brand Name: STERILE FX25RWC W/ RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 8807467
• MDR Text Key: 151601383
• Report Number: 1124841-2019-00195
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450837
• UDI-Public: (01)00699753450837
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: WP10 OR WP17
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1