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

Model Number CDI510H

Device Problem Device Issue (2379)

Patient Problem No Information (3190)

Event Date 05/20/2016

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.For this reason, terumo references evaluation conclusion code.(b)(4).Conclusions code: conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that no correct values were obtained from the shunt sensor.It is unknown when this event occurred, whether there was a delay in the procedure, whether the product was changed out, or if the surgery was completed successfully.Due to the unknown information, and the inability to obtain the necessary information from the user facility, this event is being reported.

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 24, 2016.A second follow-up will be submitted upon completion of the investigation and/or submission of new information.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 ¿ and as indicated by terumo cardiovascular systems in the initial report submitted.Method: actual device evaluated, visual inspection, manufacturing review, use testing.Results: no failure detected.Conclusions: unable to confirm complaint.The returned sample was visually inspected, during which no anomalies were noted.Using the cdi 500 and cdi 540, gas calibration was attempted on the returned sample.The calibration was successful.The sample was then performance tested by linking it within a circuit of buffer solution and reading the output values.No errors were seen during the performance test, and all values were displayed.The testing conducted on this sample was performed using the same buffer solution and gas settings as the testing of a retention sample.The values displayed from each test were similar.Review of the device history records revealed no manufacturing issues.This complaint was unable to be confirmed.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: SHUNT SENSOR SYS500
• Type of Device: BLOOD GAS MONITOR
• 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: 5747826
• MDR Text Key: 48106649
• Report Number: 1124841-2016-00256
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972962
• 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,Followup
• Report Date: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: CDI510H
• Device Catalogue Number: N/A
• Device Lot Number: TP07D
• Other Device ID Number: (01)00699753160767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2015
• 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