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U.S. Department of Health and Human Services

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

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 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 Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/20/2017
Event Type  malfunction  
Manufacturer Narrative
During laboratory analysis, product surveillance technician (pst) observed that there were no issue with core monitor functions. The monitor completed the boot process without any failures or error codes. The system successfully performed a sample calibration and it demonstrated consistent intensity values over a duration of several hours.
 
Manufacturer Narrative
The service repair technician (srt) replaced the hematocrit saturation module (h/sat) sensor. The monitor successfully passed startup self-diagnostic test with no errors. 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.
 
Manufacturer Narrative
(b)(4). Evaluation is in progress, but not yet concluded.
 
Event Description
It was reported that during use of the device for a cardiopulmonary bypass procedure (cpb), the hematocrit saturation module (h/sat) was reading inaccurately. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient. Per clinical review: the certified clinical perfusionist (ccp) has seen 3 times, with the most recent occurrence being (b)(6) 2017, error messages that he either resolves or that resolve itself. (he cannot recall the error messages) due to the concern that the unit is giving errors, he had concerns about the true accuracy of the values being displayed during the procedure. This incident occurred on bypass and the ccp opted to not change out the unit. According to the cpp the unit passed calibration, and in-vivo calibration was performed with values stored in the unit. The surgical procedure was completed successfully, and there was no harm nor blood loss to the patient.
 
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Brand NameCDI BLOOD PARAMETER MONITORING SYSTEM 500
Type of DeviceMONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
Manufacturer Contact
eileen dorsey
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key6973872
MDR Text Key247800813
Report Number1828100-2017-00487
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
Type of Report Initial,Followup,Followup
Report Date 02/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number500AHCT
Device Catalogue Number500AHCT
Other Device ID NumberGTIN: (01)00886799001622
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2001
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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