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

Model Number 500AHCT

Device Problems Loose or Intermittent Connection (1371); Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the hematocrit saturation module (h/sat) sensor cable was loose creating inaccurate h/sat reading.Example of reading: thirty-one reading was actually a twenty-two.The device was not changed out, as tension was applied on cable and the blood parameter monitor (bpm) corrected to appropriate value.They also used laboratory results to compare.The surgical procedure was completed successfully.There were no delays, no blood loss, or no adverse consequences to the patient.Per the clinical review on (b)(6) 2014: the blood parameter monitor (bpm) passed the color-chip test during set-up and boot-up of the device.During cpb, the h/sat data became erratic with values displaying dashes (---) or values being inaccurate.The inaccuracies were obvious and known to the user as the values changed dramatically, in spite of no dramatic clinical changes.An example ws the hematocrit was reading about twenty-two to twenty-three percent and closely matching the value of a laboratory analyzer and in just a few minutes with clinical changes, the hematocrit jumped to thirty-one percent.The perfusionist (ccp) felt the issue was with the cable (at junction to the probe head) as if the cable was flexed, reasonable values returned and would be displayed intermittently.The device was not changed out during the procedure and laboratory analyzer values were used to manage the patient (not the bpm values).The procedure was completed successfully, without delay and without associated blood loss (adult patient).There was no patient harm observed or reported.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

• 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: 3834758
• MDR Text Key: 4406771
• Report Number: 1828100-2014-00173
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2014

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: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2014
• Initial Date FDA Received: 03/20/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: LABORATORY ANALYZER