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

Model Number 3CX*RX15RE30

Device Problem Unable to Obtain Readings (1516)

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

Event Date 07/11/2019

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 setup, the faulty temperature probe was unable to register a temperature reading.As per the user facility, they did not change out the product; bypassed the temperature reading and continued with the surgery.  no known impact or consequence to patient.Product was not changed out.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 july 31, 2019.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 11, 3331, 4114, 3259, 4307).Method code #1: 11 - testing of device from same lot/batch retained by manufacturer.Method code #2: 3331 - analysis of production records.Method code #3: 4114 - device not returned.Results code: 3259 - improper physical structure.Conclusions code: 4307 - cause traced to component failure.The affected sample was not returned for evaluation, so a thorough investigation could not be completed.A representative retention sample from the same product/lot number combination was tested and found to be functioning properly.The root cause of the issue has been determined to be a high insertion force during assembly of the thermistor into the oxygenator module coupled with exposure to extreme temperature fluctuations.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: 8848185
• MDR Text Key: 159594849
• Report Number: 1124841-2019-00207
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450134
• UDI-Public: (01)00699753450134
• Combination Product (y/n): N
• PMA/PMN Number: K151389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 3CX*RX15RE30
• Device Catalogue Number: N/A
• Device Lot Number: XC04
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1