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 Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per subsidiary, during set-up the monitor was adjusted to match the sensors value.The blood gas from the lab analyzer showed 4.0 but when it was entered into the blood parameter monitoring (bpm) the value decreased to around 1.0 to 2.0 within a few minutes.The bpm was calibrated 10 times and the shunt sensor was replaced but the issue remained.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, abnormal potassium (k+) values were displayed.As a result, an alternate device was employed.The surgical procedure was completed successfully with one cubic centimeter (cc) of blood loss.There was no delay, nor adverse consequences to the patient.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.(b)(4).

Event Description

Per clinical review: the blood parameter monitor (bpm) was used on an extracorporeal membrane oxygenation (ecmo) patient and the information we currently have is that the potassium (k+) code was placed in the monitor, and the user states that after a store recall incident the value of 4.0 meq/l drifted down to 1.0 and 2.0 meq/l.Recalibration was done this was for in-vivo approximately 10 times, and each time the entered value decreased.Ecmo is off label use for the bpm, and it is not known how long the bpm and the shunt sensor was in use for this patient.It is also not known if the second shunt sensor placed in the ecmo circuit was gas calibrated and if the k+ value was placed in the monitor for the second shunt sensor.It is noted after the second sensor showed the same result, the team exchanged the bpm, without seeing a resolve in the k+ value.The occurrence did not delay the ecmo run/procedure.There was 1.2cc of blood loss associated with a change out in the shunt sensor.There was no harm associated with this event.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed the blood parameter monitor (bpm) to pass all startup self-diagnostics with no errors and was gas calibrated successfully.The pst placed the monitor in operate mode for 16 hours.After six hours the potassium (k+) value remained as set via in vivo.After 16 hours the k+ reading had increased by did not drop.

Manufacturer Narrative

The reported complaint was not confirmed.During blood loop analysis, the unit did not exhibit the reported inaccuracies.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 48108 ; 7346634145
• MDR Report Key: 7075507
• MDR Text Key: 93832598
• Report Number: 1828100-2017-00545
• 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,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• 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
• Other Device ID Number: GTIN (01)00886799001646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-11/08/2011-026-C
• Patient Sequence Number: 1