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

Model Number 500AHCT

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2015

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, on the blood parameter monitor (bpm) screen, all the values appeared with "a low values." they changed the bpm and the same "low" values appeared.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.During the laboratory evaluation, a shunt sensor was attached to arterial blood parameter monitor (bpm) module and only two out of four readings were flashing "low"; ph and partial pressure of oxygen (po2).All other readings were not flashing "low," pco2 was flashing "high." two bpm channels were flashing a "low" status (ph and po2) and were reset in-vivo, monitor accepted and was placed in operate mode for an hour.The bpm values stayed within range and did not go "low.".

Manufacturer Narrative

The reported complaint was not confirmed.This monitor has the 1.65 software, no upgrade for 1.69 and the blood parameter monitor (bpm) was found to have the housing separated and has not been potted.Both of these could have contributed to the issue observed but cannot be directly lied to the issue.The unit was be sent to service to be brought to manufacturers specifications before being returned to the customer.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

Per the clinical review on (b)(6) 2015: according to the initial report, "low" alert indication was displayed for most of the values on the blood parameter monitor (bpm) and the user changed out the shunt sensor without improved performance.The "low values" were seen in only the shunt sensor measurement fields, not hematocrit saturation module (h/sat) data fields.The shunt sensor was gas calibrated with the calibrator 540 and the was gas calibrated with the calibrator 540 and the calibration was successful.All measured values appeared lower than expected and "low" was flashing for many of w the measures.An in-vivo calibration in the early minutes of cardiopulmonary bypass (cpb) did not improve the accuracy of the measurements.The user elected to power down the bpm and power back up in attempt of getting better accuracy and this maneuver did not help.Next, the shunt sensor was changed out and again the measured values were lower than the laboratory measured values.Then, the bpm was changed out and according to the perfusion team this resulted in accurate measures.The case was completed successfully, without delay and without delay and without associated blood loss.There was no harm observed.

• 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: 4827121
• MDR Text Key: 5836647
• Report Number: 1828100-2015-00502
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K972962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor,distributor,fo
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-08/19/2010-004-C
• Patient Sequence Number: 1