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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 500AVHCT
Device Problem Incorrect Measurement (1383)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/30/2018
Event Type  malfunction  
Manufacturer Narrative
This complaint is related to (b)(4) / medwatch #1828100-2018-00442.
 
Event Description
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the unit provided inaccurate measurements for partial pressure of carbon dioxide (pco2) and ph levels.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: it was stated to date that the perfusionist has had four different occurrences, with the most recent occurrence being (b)(6) 2018 of similar inaccuracies with the same blood parameter monitoring (bpm) system.The team calibrates their shunt sensors with gas a and gas b, along with placement of the potassium (k+) code into the monitor prior to every procedure.The team calibrates the values with the first in-vivo.The perfusionist stated that the variances of all the values (ph, pco2) are out of the accuracy specifications.During this procedure the pco2 after approximately three hours on bypass had pco2 values that were close to 40 millimeters of mercury (mmhg) off from the arterial blood gas (abg).The ph had a large delta from the abg machine also.The ph on the abg was 7.51, the bpm was reading 7.26.The pco2 on abg was 25mmhg, the bpm was reading 60 mmhg.According to the perfusionist, after the in-vivo, at the three hour mark, the unit did track the abg values much better.It was also stated that they know their prime solution has a ph of between 7.0 and 7.8 units, and that the blood during the procedures are within that range.The team has not changed any of their clinical practices recently to have a change in what their expectations of the clinical parameter values should be.They have not changed the temperatures drastically, and always do an in-vivo with all subsequent gases.Secondarily, during this procedure, the perfusionist stated that they cooled to approximately 28 degrees celsius (c).The team did not change out the monitor or the shunt sensor during the procedure.The team mitigated the questionable values by using the epoch blood gas analyzer.There was no blood loss or harm associated with the occurrences.There was no delay in the surgical procedures due to the concerns about the bpm.
 
Manufacturer Narrative
The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the monitor to pass startup self-diagnostics with no failure.The monitor was placed in its service mode and a blood parameter module (bpm) standard reference sensor (srs) test was perform.The monitor's arterial bpm failed several channels which were above service mode limits of 20% to -30% for drift.The monitor was placed in its operate mode with a green srs sensor attached and was operated for over three hours, the ph and carbon dioxide (c02) values of the arterial bpm did not drift.No blood loop testing was done as the inaccuracy was a result of temperature difference.After the temperature transition, the user facility was able to stabilize the shunt.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
Event Description
Additional information was received from the manufacturer's clinical specialist, that the patient's ph on the arterial blood gas (abg) was 7.51 and the blood parameter monitor (bpm) was reading 7.26.The user facility has not changed the temperature drastically and always do an in-vivo with all subsequent gases.Secondarily, during this procedure, the perfusionist stated that they cooled the patient approximately 28 degrees celsius (c).
 
Manufacturer Narrative
Evaluation is in progress, but not yet concluded.
 
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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 Key7903256
MDR Text Key121725169
Report Number1828100-2018-00490
Device Sequence Number1
Product Code DRY
UDI-Device Identifier00886799001646
UDI-Public(01)00886799001646(11)990708
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
Report Date 12/13/2018
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 Number500AVHCT
Device Catalogue Number500AVHCT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/06/2018
Initial Date FDA Received09/24/2018
Supplement Dates Manufacturer Received10/19/2018
12/12/2018
Supplement Dates FDA Received11/09/2018
12/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number1828100-08/07/15-002-C
Patient Sequence Number1
Treatment
EPOCH BLOOD GAS ANALYZER
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