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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 Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/14/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during use of the device for a cardiopulmonary bypass procedure, the venous probe was reading 100%. The perfusionist (ccp) recalibrated but it would keep going back to 100%. Also, the unit kept saying "disconnected" but it wasn't. The device was not changed out, as the customer used the bpm for the case. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient. Per clinical review: on (b)(6) 2016 an email response from the ccp regarding this incident was received. According to the ccp, a cdi 500 was being used for a cardiopulmonary bypass procedure. The unit displayed a slope calibration error during set-up, but passed color chip test. The ccp mentioned that the h/sat probe was securely attached to the cuvette, but that they received a disconnect error. Approximately 15 minutes into the procedure, the svo2 continuously displayed at 100 % and this was obvious to the user not to be accurate. Repeat in-vivo calibrations were performed, but the svo2 data continued to be inaccurate. The users elected to continue use of the cdi 500 for the remainder of the procedure. There was no impact to the patient as a result. There was no delay in the actual extracorporeal membrane oxygenation (ecmo) procedure and there was no observed harm.
 
Manufacturer Narrative
(b)(4). The reported complaint was confirmed. The product surveillance technician (pst) placed the hematocrit saturation (h/sat) probe in operate mode and was able to display values. No disconnect errors were observed. Visual inspection revealed that the h/sat probe had a broken spring clip. This allowed for movement of the cuvette when attached to the probe. An insecure connection between the probe and the cuvette could affect the functionality of the probe and cause cuvette disconnect errors. The product will be sent to service to be brought to manufacturers 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.
 
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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 CORP.
6200 jackson road
ann arbor MI 48103
Manufacturer Contact
jan winder
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key5414359
MDR Text Key38092638
Report Number1828100-2016-00065
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 08/25/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2016
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 Manufacturer08/04/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/28/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number1828100-11/08/11-026-C

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