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

Model Number 500AVHCT

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, there was difficulty in measurements with the blood parameter monitor (bpm).The device was not changed out.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per the clinical review on (b)(6) 2014: during the start of using the bpm (in operate mode), there were dashes "---" displayed for ph, pco2, and p02 for arterial shunt sensor and the word "low" appeared in each of these windows.This indicates the measurements are below the low limit set by the user or below the default settings from the factory.According to the clinician, the blood was normally oxygenated and they felt that low blood gas measures (indicated by "---" on the bpm) were not reflective of the actual conditions.In addition, no error codes were displayed.(b)(4) / mdr #1828100-2014-01066 clinical review continued: the (b)(6) subsidiary reported that the customer's clinical team performed a number of mitigations to respond to these issues.The bpm was placed in the standby mode and then returned to operate and "---" were still displayed for ph, pco2, and po2.The shunt sensor was removed from the bpm and then re-connected to the bpm, and again no improvement.The shunt sensor was removed from the bpm and replaced with another sensor from the same lot number and again the "---" remained.The bpm was powered down, re-booted and then there were reasonable values displayed for ph, pco2, and po2.There were no other issues indicated for the remainder of the procedure.The procedure was completed successfully, without delay of the surgical procedure and without associated blood loss.There was no harm observed.

Manufacturer Narrative

The problem was not noted during preparation and found after the initiation of the procedure.The values on the shunt sensor at the a-side are indicated as [----].The values on ph, partial pressure of oxygen (p02), and partial pressure of carbon dioxide (pco2) were indicated as [----].The values on the v-cuvette were displayed in the normal manner.There was no specific error message.Po2, ph and pco2 were indicated "low".Blood was normally oxygenized.

• 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: 4307565
• MDR Text Key: 16307164
• Report Number: 1828100-2014-01066
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K972962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• 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
• Date Manufacturer Received: 11/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1