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

Model Number 500AHCT

Device Problems Corroded (1131); Low Readings (2460)

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

Event Date 04/11/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device, the potassium (k+) value suddenly dropped to about "2" and a low value alarm occurred.The blood parameter monitor (bpm) was used for percutaneous cardiopulmonary support (pcps) patient for about two weeks.The issue was not resolved by replacing shunt sensor.As a result, an alternate device was employed.The surgical procedure was completed successfully.There were no delays, no blood loss, or no adverse consequences to the patient.

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
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7466344145
• MDR Report Key: 3897075
• MDR Text Key: 16552523
• Report Number: 1828100-2014-00383
• 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: 04/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• 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: 05/09/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2014
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1