MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500

Model Number 500AHCT

Device Problem Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.The customer just received this unit back from service in mid-december 2015.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the blood parameter monitor (bpm) temperature was ten degrees too low.The device was not changed out, as they used the bpm unit for the case.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

During the laboratory evaluation, the reported issue was duplicated.The product surveillance technician (pst) observed blood parameter monitor (bpm) does not go to specific temperature per the complaint, testing showed 7-8 degrees off at high temperature (40 degrees celsius).Monitor passed startup self-diagnostics with no errors observed.The product will be sent to service to be brought to manufacturers specifications before being returned to the customer.

Event Description

Per the clinical review on 27-jan-2106: this blood parameter monitor (bpm) unit had recently been returned from the manufacturer for service.During use, in the operate mode, the shunt sensor temperature was reading significantly lower than the arterial blood temperature especially as the patient's blood was being rewarmed.When the patient was fully rewarmed and the arterial blood normothermic (37 degrees celsius), the arterial shunt sensor temperature did not measure (display) above 28-30 degrees celsius.This behavior was seen with multiple shunt sensors that included multiple sensor lots.These same shunt sensor lots were used with other bpm monitors, and these other monitors did not exhibit this same behavior.This does not appear to be a shunt sensor issue.The case was completed successfully, without delay and without associated blood loss.There was no harm reported.

Manufacturer Narrative

The reported complaint was confirmed.The investigation determined that the thermistors were not built per the specifications, where the drawing note requires the thermistor chip to be located within first 0.050 inches of the sleeve.Further investigation at the supplier determined that the chip location did not transfer from design to manufacturing at the supplier.Further investigation also identified improper supplier controls at the time to ensure that the part met specification.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: CDI BLOOD PARAMETER MONITORING SYSTEM 500
• Type of Device: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5396165
• MDR Text Key: 37043327
• Report Number: 1828100-2016-00039
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-03/08/16-001-R
• Patient Sequence Number: 1
• Treatment: S5 TEMPERATURE MONITOR