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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 Problem Incorrect Measurement (1383)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2018
Event Type  malfunction  
Manufacturer Narrative
Evaluation is in progress, but not yet concluded.As per the perfusionist, the po2 on the bpm was reading 15 when it was actually 110 from the post oxygen (o2) blood gas.The bpm was calibrated twice and it made no change in the reading.Prior to switching to another device, the cell was flushed out and calibrated again but did not change the results.The bpm was being used during an extracorporeal membrane oxygenation (ecmo) procedure.
 
Event Description
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the partial pressure of oxygen (po2) on the blood parameter monitor (bpm) was reading very low.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
 
Manufacturer Narrative
The reported complaint was not confirmed.The service repair technician (srt) observed the device to pass all applicable testing with no issues.The unit operated to 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
During laboratory analysis, the product surveillance technician (pst) observed the monitor to function as expected.There were no issues encountered while performing sample functions.
 
Event Description
Per clinical review: during an extracorporeal membrane oxygenation (ecmo) run they had a partial pressure of oxygen (po2) reading that was 15mmhg when the arterial blood gas (abg) machine was reading 110 mmhg.For the ecmo procedure, the unit was calibrated without issue, and once initiation of ecmo occurred, the unit was in-vivo calibrated without issue.The perfusionist stated that a few days into the ecmo procedure, the po2 reading was reading 15mmhg.The team did a store recall and placed the recalled value of 110 mmhg into the machine, and then went to operate mode and the blood parameter monitor (bpm) was reading a value of 15 mmhg.They opted to then change out the shunt sensor to discern if the problem was with a shunt sensor or with the monitor.The team calibrated the shunt sensor and unit without issue.They re-established flow through the shunt sensor, and did an in-vivo calibration.The unit right after the in-vivo calibration was reading a po2 of 15 mmhg.Therefore, they exchanged the monitor and continued the ecmo without issue.All other parameters were within range during this period, and the patient was normothermic the entire ecmo.The exchange of the shunt sensor resulted in a blood loss of 1.3 milliliters (ml) of blood.There was no harm or delay in procedure due to the event.
 
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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 CORPORATION
6200 jackson road
ann arbor MI 48103
MDR Report Key8174595
MDR Text Key131726167
Report Number1828100-2018-00646
Device Sequence Number1
Product Code DRY
Combination Product (y/n)N
PMA/PMN Number
K133658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 04/23/2019
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/28/2018
Initial Date FDA Received12/18/2018
Supplement Dates Manufacturer Received12/19/2018
03/07/2019
04/05/2019
Supplement Dates FDA Received01/11/2019
03/29/2019
04/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number1828100-11/08/2011-026-C
Patient Sequence Number1
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