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 Problem Invalid Sensing (2293)

Patient Problem No Patient Involvement (2645)

Event Date 10/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during the use of the device for a non-clinical activity, the monitor and its associated hsat probe was used as part of accuracy testing on blood loop.It failed to meet the system's accuracy limits by 0.1% as stated in the operator's manual for oxygen saturation value (so2) at blood temperature 15 degrees celsius (lower limit for temperature operating range).There was no patient involvement.

Manufacturer Narrative

Per product surveillance technician (pst), hematocrit saturation module (h/sat) probe fails to meet specification by means documented by blood loop lab.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

The reported complaint was confirmed.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: 6067470
• MDR Text Key: 59047290
• Report Number: 1828100-2016-00709
• 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,Followup
• Report Date: 07/25/2017

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: 05/23/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2016
• Initial Date FDA Received: 10/31/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 07/13/2017
• Supplement Dates FDA Received: 11/22/2016; 06/14/2017; 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-11/08/11-026-C
• Patient Sequence Number: 1