MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SHUNT SENSOR SYS500; BLOOD GAS MONITOR

Model Number CDI510H

Device Problem Failure to Calibrate (2440)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Date 09/30/2019

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 the shunt sensor would not calibrate.Another calibrator was used to check if it wasn't a calibrator fault which they confirm.It is unknown when the event occurred, whether the product was changed out, whether there was blood loss, if there was any effect on the patient or results of the surgery.Due to the unknown information for this event, it is being reported.Terumo continues to attempt to gain more information regarding this event from the user facility.

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 october 21, 2019.Upon further investigation of the reported event, the following information is new and/or changed: b5 (updated describe event or problem).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 2645, 10, 11, 3331, 213, 67).Patient code: 2645 - no patient involvement.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: 213 - no device problem found.Conclusions code: 67 - no problem detected.The returned sample was visually inspected upon receipt with no noted anomalies on the shunt body or sparger assembly.The unit was then set up for gas calibration with the cdi 500 and cdi 540.Gas calibration was successful with no errors returned.The failure mode seen by the customer could not be recreated, so a definitive root cause could not be identified.Potential root causes include opening the pouch more than 24 hours prior to calibration, not fully seating the bpm assembly into the calibrator pocket or emptying the buffer solution prior to calibration.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

New information was receive indicating that the event occur during setup.The product was changed out and the surgery was completed successfully.

• Brand Name: SHUNT SENSOR SYS500
• Type of Device: BLOOD GAS MONITOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 9215850
• MDR Text Key: 164340781
• Report Number: 1124841-2019-00287
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00699753160767
• UDI-Public: (01)00699753160767
• Combination Product (y/n): N
• PMA/PMN Number: K972962
• 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: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: CDI510H
• Device Catalogue Number: N/A
• Device Lot Number: XF06G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1