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

Model Number 500AVHCT

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Dysphasia (2195)

Event Date 05/28/2015

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) has the following inaccurate values during bypass: high ph, high partial pressure of carbon dioxide (pco2), and low partial pressure of oxygen (po2).The device was not changed out, as they continued use as the unit was accurate after the first in-vivo calibration.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

This issue has occurred since the software upgrade to 1.69.The customer is not sending the monitor in for evaluation or repair, as it is accurate after the first in-vivo calibration, per clinical services.This complaint is related to the following 21 mdr #s: 1828100-2015-00580, 1828100-2015-00581, 1828100-2015-00582, 1828100-2015-00587, 1828100-2015-00588, 1828100-2015-00589, 1828100-2015-00590, 1828100-2015-00591, 1828100-2015-00592, 1828100-2015-00593, 1828100-2015-00596, 1828100-2015-00597, 1828100-2015-00598, 1828100-2015-00600, 1828100-2015-00601, 1828100-2015-00602, 1828100-2015-00603, 1828100-2015-00604, 1828100-2015-00615, 1828100-2015-00616, 1828100-2015-00617.Clinical services has spoken with the perfusionist (ccp) on a number of occasions since the blood parameter monitor (bpm) units have been updated from software version 1.65 to version 1.69.They have noticed a number of issues with accuracy since the update of the software.They have observed, on multiple bpm units, that prior to the in-vivo calibration the ph, pco2, and po2 measures do not agree with the laboratory analyzed values.Prior to 1.69 (version 1.65), these measured bpm values were close to laboratory analyzed values throughout cpb (including prior to the first in-vivo calibration).On three consecutive days, with the same bpm and the same ccp was involved for all of these cases.The ccp calibrated the shunt sensors with the calibrator 540 prior to cpb and he did not expose the shunt sensors to the prime solution as the sensors were not open until about one minute post cpb.In summary, the same exact practice was done for these three consecutive cases.In the first case on (b)(4) 2015; the following measures were seen at the first in-vivo calibration: ph=7.27 (bpm) and 7.35 (lab analyzer); pco2 = 42 (bpm) and 50 (lab analyzer); po2 = 337 (bpm) and 492 (lab analyzer).In the second case on (b)(4) 2015; the following measures were seen at the first in-vivo calibration: ph =7.18 (bpm) and 7.25 (lab analyzer); pco2 = 47 (bpm) and 48 (lab analyzer); po2 = 414 (bpm) and 500 (lab analyzer).In the third case on (b)(4) 2015; the following measures were seen at the first in-vivo calibration: ph=7.59 (bpm) and 7.31 (lab analyzer); pco2 = 88 (bpm) and 53 (lab analyzer); po2 = 266 (bpm) and 395 (lab analyzer).According to the ccp, after the first in-vivo calibration, the bpm measures were close and reasonable as compared to the lab analyzer.The ccp claims that with new version 1.69, the bpm can't be trusted prior to the first in-vivo calibration and the in-vivo calibration is often not done until about 15-20 minutes into cpb.The early minutes of cpb are critical as the ccp is assessing a number of device functions and patient and procedural functions.This includes oxygenator performance, oxygen delivery and consumption, carbon dioxide production and removal, adequacy of blood flow, patient metabolic rate, depth of anesthesia and other measures.According to the ccp, since the bpm can't be trusted during these early minutes, additional and earlier laboratory sampling is required and patient interventions could be delayed.The case(s) was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

The reported complaint was not verifiable.Per the 1.69 software upgrade, no accuracy is claimed until after an in-vivo calibration is performed.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 SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4912821
• MDR Text Key: 15306972
• Report Number: 1828100-2015-00594
• 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: 08/14/2015

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2015
• Initial Date FDA Received: 07/10/2015
• 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
• Treatment: LABORATORY ANALYZER