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 Invalid Sensing (2293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is related to mdr #1828100-2016-00071.During the laboratory evaluation, the product surveillance technician (pst) observed temperatures ranging from 19.2 to 34.8 degrees celsius on the bpm, which is wider than the range reported in the complaint.However, temperature is incorrect throughout operating range of the unit.The difference is wider toward the upper and lower ends of the specified range.Bpm temperature was monitored concurrently with a bpm from the lab platter.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the temperature range was only 26-28 degrees on the blood parameter monitor (bpm).The device was not changed out, as they used arterial temp from base, then input the data (temperature) into the i-stat.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)(4) 2016: the perfusionist (ccp) stated that a bpm unit was sent to them as a back-up, and during first usages the temperature as measured at the shunt sensor was reading up to ten degrees lower than the arterial blood temperature.In addition, it rarely moved outside of a 26-28 degree celsius range even when the patient was being rewarmed to 37 degrees celsius.This behavior is observed each time they use this monitor and has occured with usage of multiple shunt sensors.They continue to use this monitor, until a back-up loaner is provided by the manufacturer.Cases have been completed successfully, without delay and without associated blood loss.There has been no harm observed.

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: 5430112
• MDR Text Key: 38143554
• Report Number: 1828100-2016-00072
• 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
• Report Date: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• 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: 02/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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