MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION PRESCRIPTIVE OXY PACK - CAPIOX; BLOOD GAS OXYGENATOR

Model Number 74281

Device Problem Unable to Obtain Readings (1516)

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

Event Date 06/03/2019

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 during cardiopulmonary bypass, the thermistor did not register temperature.As per the user facility, while they were giving heparin, they discovered that the arterial temperature was not working.The perfusionist replaced the thermistor wire with another and the temperature still did not read.No known impact or consequence to patient.The 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 june 21, 2019.  upon further investigation of the reported event, the following information is new and/or changed: 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: 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 and device evaluation).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (identification of evaluation codes 10, 11, 3331, 3259, 4307).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: 3259 - improper physical structure.Conclusions code: 4307 - cause traced to component failure.The affected sample was returned for evaluation and was checked to confirm that the arterial temperature port was non-functional.A representative retention sample from the same product/lot number combination was tested and found to be functioning properly.An engineering investigation and capa have been initiated to determined a definitive root cause.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: PRESCRIPTIVE OXY PACK - CAPIOX
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 8724136
• MDR Text Key: 148973346
• Report Number: 1124841-2019-00173
• 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: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 74281
• Device Catalogue Number: N/A
• Device Lot Number: XC18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• 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