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 500AHCT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.(b)(4).The issue occurred during testing by hospital upon receiving loaner unit from service.As per customer, the power plug to ground plug resistance was greater than.5 ohms.They tried multiple power cords and verified with calibrated safety analyzer and then with an ohm meter.

Event Description

It was reported that during the use of the device for a non-clinical activity, the monitor did not pass the hospital electrical test as the resistance was too high.There was no patient involvement.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) found the ground resistance measured within the manufacturer's specifications.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

(b)(4).The reported complaint was not confirmed.Per service repair technician (srt) during service repair the unit ground resistance was measured within specification.The unit operated to the manufacturer's specifications.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: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6566212
• MDR Text Key: 75314005
• Report Number: 1828100-2017-00234
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2017

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: Health Professional
• Device Model Number: 500AHCT
• Device Catalogue Number: 500AHCT
• Other Device ID Number: GTIN (01)00886799001622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2017
• Initial Date FDA Received: 05/15/2017
• Supplement Dates Manufacturer Received: 06/13/2017; 08/14/2017
• Supplement Dates FDA Received: 07/07/2017; 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2009
• 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