MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. CDI 100 HEMATOCRIT/OXYGEN SATURATION MONITORING SYSTEM; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI 100 HEMATOCRIT/OXYGEN

Model Number 100

Device Problems Fluid/Blood Leak (1250); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported issue was confirmed by product surveillance technician (pst).The 6v battery has cracked open in multiple places and leaked its internal fluid.Also, corrosion has formed inside the battery placement area.There was no external power supply or 6v battery available.The battery has been moved to service department for disposition and will be scrapped.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

It was reported that during the use of the device for a non-clinical activity, the monitor did not power up at all.There was no patient involvement.

• Brand Name: CDI 100 HEMATOCRIT/OXYGEN SATURATION MONITORING SYSTEM
• Type of Device: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI 100 HEMATOCRIT/OXYGEN
• 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: 6285763
• MDR Text Key: 66333632
• Report Number: 1828100-2017-00044
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100
• Device Catalogue Number: 100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2002
• 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