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 Date 10/27/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the blood parameter monitor (bpm) was reading falsely high potassium (k+) levels.As a result, an alternate device was employed.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 this behavior has occurred since the notice of field correction (nfc) (bpm potting) and did not seem to be an issue prior.The issue is the k+ continuously drifts up on the bpm in cases where cardioplegia is used.In cases where cardioplegia (high k+ solution) is not used, the k+ accuracy is acceptable.The drifting occurs after the first in-vivo calibration, where the bpm is matched to the laboratory analyzed result.After the calibration, the k+ rises to levels higher than the laboratory and in some cases, the bpm measured k+ value is 2-3 mmol/l higher than the laboratory analyzed sample.Even after multiple in-vivo recalibrations, the k+ continues to drift up.Other bpm parameters are reasonably in agreement with the laboratory analyzer.The cases are completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.This complaint is related to mdr # 1828100-2014-00554 and 1828100-2014-00977.

• 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: 4279249
• MDR Text Key: 5006230
• Report Number: 1828100-2014-00976
• 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
• Date Returned to Manufacturer: 10/30/2014
• 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
• Date Device Manufactured: 09/01/2009
• 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: LABORATORY ANALYZER