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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 03/07/2018
Event Type  malfunction  
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 (cpb) procedure, there was a temperature discrepancy. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient. Per clinical review: the perfusionist set up and calibrated his blood parameter monitor (bpm) shunt sensors with both gas a and gas b, along with placing the potassium (k+) code in the monitor prior to initiation of bypass on (b)(6) 2018. Ten minutes into the cpb procedure, he noticed that his sensor temperature was reading 40. 5 celsius (c) and the patients actual temperature was listed as 37. 0 c. This temperature difference was before his first in-vivo calibration. He stored his values, and then placed his in-vivo blood gas analyzer values in the bpm and just as the machine was reverting back to operate mode, the k+ parameter read 8 meq (he had placed around 4. 0 in the machine), and the machine then gave him a f101 error message. This error message is an arterial bpm hard failure. He turned the bpm off and back on, but was only able to choose a configuration without the arterial bpm. He proceeded with the unit in the hemoglobin, hematocrit saturation module (h/sat) configuration without issue. After this second complaint, the manufacturer's clinical specialist advised him that he should not use the bpm for arterial blood gas parameters, for the unit would continue giving the error message. It was reiterated that he could use it for the hsat parameters in the interim period. The incident did not delay the continuation of the surgical procedure. They supplemented the values with blood gas values from a blood gas analyzer. There was no blood loss or harm associated with the event.
 
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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 Key7381150
MDR Text Key104154352
Report Number1828100-2018-00163
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
Report Date 05/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number500AHCT
Device Catalogue Number500AHCT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2012
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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