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 500AVHCT

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 07/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The quality engineer (qe) reported that during routine testing of the device, while using the blood parameter monitor (bpm) for calibration testing in the manufacturer's (b)(4)site, it was noticed that the venous bpm probe was measuring the potassium (k+) chemistry at a much higher intensity than the other three bpm probes involved in the test.There was no patient involvement.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

Manufacturer Narrative

The reported complaint was not verifiable.Product surveillance technician (pst) and service repair technician (srt) were unable to duplicate the customer's settings.During laboratory analysis, the monitor was placed in service mode and a standard reference sensor test (srs) was successfully performed.All seven channels of the venous blood parameter monitor were under 10% for drift.Per product engineering, no blood loop testing is required; as this is not an inaccuracy issue.For the device to be inaccurate, they need blood data from customer in operating range compared to blood gas analyzer (bga).In this case, the manufacturer's elkton site is using the device as an intensity screener and they do have srs and chemistry which will read a higher range of intensity.It does not mean inaccurate, only different intensity from the stimulus provided to the device.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: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 5888675
• MDR Text Key: 53451904
• Report Number: 1828100-2016-00566
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2017

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: Other
• Device Model Number: 500AVHCT
• Device Catalogue Number: 500AVHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/27/2016
• Initial Date FDA Received: 08/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/25/2016; 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2013
• 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