MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS

Model Number 858828

Device Problem Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 01/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During the laboratory evaluation, the reported issue was duplicated.The bpm does not go to higher temperature per the water bath, testing showed 7-8 degrees off at high temperature (40 degrees celsius).The rohs thermistor installed on the bpm does not react to temperatures properly.The product surveillance technician (pst) observed no physical / cosmetic abnormalities observed with monitor.

Event Description

Upon receipt of the device, the product surveillance technician (pst) reported that the blood parameter monitor (bpm) did not track or change temperature.There was no patient involvement.

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
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; an arbor, MI 48103 ; 7346634145
• MDR Report Key: 5454152
• MDR Text Key: 38797545
• Report Number: 1828100-2016-00106
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 858828
• Device Catalogue Number: 858828
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2016
• 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