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U.S. Department of Health and Human Services

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

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TERUMO CARDIOVASCULAR SYSTEMS CORP. CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500 Back to Search Results
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.
 
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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 Key6566212
MDR Text Key75314005
Report Number1828100-2017-00234
Device Sequence Number1
Product Code DRY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133658
Number of Events Reported1
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 Number500AHCT
Device Catalogue Number500AHCT
Other Device ID NumberGTIN (01)00886799001622
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/20/2017
Initial Date FDA Received05/15/2017
Supplement Dates Manufacturer Received06/13/2017
08/14/2017
Supplement Dates FDA Received07/07/2017
08/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/09/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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