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

Model Number 500AVHCT

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, there were abnormal potassium (k+) values displayed.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, nor adverse consequences to the patient.Per clinical review: the blood parameter monitor (bpm) was used for a percutaneous cardiopulmonary support procedure.It is unknown if the k+ code was placed in the monitor, if the team isolates the sensor prior to induction of bypass, and what the ph of the priming solution is that they currently use in their practice.The user stated that after a store recall incident the value of 4.0 milliequivalent per liter (meq/l) drifted down to 2.7 and then to 1.0 meq/l in a few seconds.The team first changed out the shunt sensor with a newly calibrated shunt sensor of the same lot number.According to the information available, the second shunt gave a shunt sensor error.The information currently available does not state which sensor failed the calibration intensity.The user would have needed to make sure the sensor was engaged with the cable head, and repeat the calibration.If the error was persistent, the failing shunt sensor would need to be replaced.Secondarily, it is not confirmed if the team changed out the monitor after the replacement of the shunt sensor.The patient is noted to have mild acidosis and hyperbilirubinemia, neither would cause a swing.The occurrence did not delay the procedure.There was 1.2 cc of blood loss associated with a change out in the shunt sensor.There was no harm associated with this event.

Event Description

Additional information received indicated that the product was not changed out.

Manufacturer Narrative

The reported complaint was not verifiable since the unit was not returned to the manufacturer for evaluation.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• 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
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 7116484
• MDR Text Key: 95741133
• Report Number: 1828100-2017-00561
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• 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?: No
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-11/08/11-026-C
• Patient Sequence Number: 1