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

Model Number 500AHCT

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the potassium (k+) number kept drifting higher during the case on the blood parameter monitor (bpm).The device was not changed out, as they just continued to use the monitor.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 perfusionist (ccp) stated that k+ drift is an intermittent issue (not every case), but in this case was especially inaccurate.After cpb was initiated and cardioplegic arrest occurred, an in-vivo calibration was performed about five minutes after the completion of the cardioplegia dose.After the results were entered into the bpm, the k+ measure would drift upward.According to the ccp, an in-vivo recalibration was performed every 20 minutes and the k+ would drift between each re-calibration.During rewarming of the patient (later in cpb), the bpm measured the k+ as 8.0 mmol/l and the laboratory analyzed value was 5.7 mmol/l.According to the ccp, there were no issues with the other bpm shunt/bpm measures.The case was completed successfully, without delay and without associated blood loss.According to the ccp, more frequent laboratory analysis was needed (every 20 minutes) in this case.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: 4340550
• MDR Text Key: 5204450
• Report Number: 1828100-2014-01055
• 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: 11/18/2014

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: 11/18/2014
• Initial Date FDA Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2006
• 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
• Treatment: I-STAT