MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM CORP. TERUMO CDI 500 BLOOD PARAMETER MONITOR

Model Number 500AVHCT

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2015

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the saturated venous oxygen (svo2) on the blood parameter monitor (bpm) was reading substantially lower than it did prior to the version 1.69 software update.The device was not changed out, as they continued to use for the case.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the pt.Per the clinical review on (b)(6) 2015: the chief of perfusion (ccp) admitted that since the 1.69 software upgrade of this monitor, the svo2 measure is less than previously seen with the previous software version (1.65) and lower than their laboratory analyzer (especially prior to the 1st in-vivo calibration).Prior to the first in-vivo calibration (in the first 15-20 minutes of cpb), the svo2 measure of the bpm is consistently 10-12% points less than their independent laboratory analyzer.This means that in the early minutes of cpb, the bpm svo2 level is generally in the 55-60% range, while the laboratory analyzed svo2 is in the 65-75% range.According to the ccp, the bpm lower svo2 values were doubted in the early minutes of cpb as the color of the blood was brighter (red) than what the bpm svo2 values indicated.The ccp stated that prior to the 1.69 upgrade, the svo2 measures of the bpm and the laboratory analyzer were close in measurement.The ccp stated that after the in-vivo calibration, the svo2 would more closely match in some cases but in others the difference would remain 5-10% (with the bpm also being lower than the laboratory analyzed value).According to the ccp, accuracy of the other parameters measured with the hematocrit saturation module (h/sat) probe (hemoglobin [hgb] and hematocrit [hct] and the arterial shunt measurements (with bpm) have not been an issue with the 1.69 upgrade.Due to this issue, additional venous samples (more than with 1.65 software) are drawn.Since the other measured values of the bpm have been reasonable, the bpm has not been changed out during the procedures.Cases have been completed successfully, without delay and without associated blood loss.There has been no harm observed.

Manufacturer Narrative

The software update occurred two to the three weeks ago.This customer is not sure if this occurred on all monitors so the user facility is going to start recording values.The user facility collected 34 simultaneous coox svo2 and bpm svo2 readings from nine bpm monitors (n=1-7 samples per monitor) during stable cpb.The average bpm svo2 = 75.1 (+/- 7.6) and the coox svo2=75.9 (+/- 6.5).The mean difference was 0.7% and the difference was not significant.The bpm svo2 correlated with the coox svo2 (n=34, r-sq=0.12, p=0.064).As the actual coox svo2 increased above 75%, the bpm read lower than the actual coox svo2 value (r-sq = 0.25, p=0.0026).At an actual coox svo2 = 85%, the bpm read 5-7% lower.At an actual coox svo2 = 65%, the bpm read 5-7% higher.

Manufacturer Narrative

The reported complaint was not verifiable.No product was returned for evaluation.Diligence was performed to obtain the serial numbers and have parts returned, but the customer does not plan on returning any units.The perfusionist (ccp) sent the manufacturer their own evaluation of nine monitors over several cases and plotted data of blood parameter monitor (bpm) values versus their own lab analyzer.As this was not verified by the manufacturer's personnel, it cannot be used for confirmation of the issue.The customer data was sent to the bpm subject matter expert (sme) for review.The ccp continues to use the units.No additional action will be taken at this time.

• Brand Name: TERUMO CDI 500 BLOOD PARAMETER MONITOR
• Type of Device: CDI 500
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEM CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road ; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4777984
• MDR Text Key: 5813667
• Report Number: 1828100-2015-00391
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/11/2015

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 Number: 500AVHCT
• Device Catalogue Number: 500AVHCT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2015
• Initial Date FDA Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-08/07/15-002-C
• Patient Sequence Number: 1