MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO CDI 500 BLOOD PARAMETER MONITOR

Model Number 500AHCT

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the arterial temperature of the shunt sensor was reading much higher than oxygenator arterial temperature probe.The device was not changed out.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per the clinical review on (b)(6) 2014: the user facility¿s biomedical engineer (biomed) reported the incident as arterial sensor issue and no other information was reported.According to the perfusionist (ccp), during cpb the arterial shunt sensor temperature measurement was reading much higher than the arterial blood temperature measured at the oxygenator outlet.According to the ccp, the arterial blood temperature of the oxygenator was measured at 36-37 degrees celsius and the blood parameter monitor (bpm) shunt sensor was displaying an arterial blood temperature of 42-43 degrees celsius.The ccp stated, it was obvious this measurement was not accurate as the water temperature of the water directed to the oxygenator was only 38 degrees celsius.The ccp stated the other parameters measured by the shunt sensor were accurate so the sensor and bpm were used for the remainder of the procedure and the arterial temperature of the shunt was disregarded.The procedure was completed successfully, without delay and without associated blood loss and there was no harm observed.

• Brand Name: TERUMO CDI 500 BLOOD PARAMETER MONITOR
• Type of Device: CDI 500
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4279261
• MDR Text Key: 5011193
• Report Number: 1828100-2014-01039
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/27/2014

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 Model Number: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2014
• Initial Date FDA Received: 11/19/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1