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

Model Number CDI510H

Device Problem Calibration Problem (2890)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the actual device; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow up report when the investigation is complete and more information becomes available.(b)(4).Results: results pending completion of evaluation.Conclusions: conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that the sensor was not working after calibration.There were no values on display on arterial values.It is unknown when this event occurred, whether the product was changed out, or 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 january 11, 2017.(b)(4).The sample was not returned for evaluation.A review of the device history record revealed no manufacturing anomalies.A retention sample from the same product code/ lot number combination was obtained.The retention sample was visually inspected, during which no anomalies were noted.Using the cdi 500 and cdi 540, gas calibration was attempted on the retention 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.A definitive root cause could not be determined; therefore, this complaint is not 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 CORP.; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6244204
• MDR Text Key: 64601939
• Report Number: 1124841-2017-00005
• 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
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: CDI510H
• Device Catalogue Number: N/A
• Device Lot Number: UL26A
• Other Device ID Number: (01)00699753160767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 01/11/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2016
• 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