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

Model Number 500AVHCT

Device Problems Circuit Failure (1089); Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2015

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, when the blood parameter monitor (bpm) was plugged into alternating current (a/c) power, the unit was not recognizing a/c power and the batteries were depleted.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The reported complaint was confirmed.The product surveillance technician (pst) was able to duplicate the reported issue.The bpm does not turn on with a/c power as well with 12v battery.The 12v battery was not being charged properly.The bpm charging light emitting diode (led) was blinking and should not be, but should be a constant "on" steady state with a/c power applied.The pst found capacitor c19 has ruptured, which is located on the monitor's battery charging circuitry on the monitor aux printed circuit board assembly (pcba).The product will be sent to service to be brought to manufacturer's 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.

• 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: 4938363
• MDR Text Key: 6192873
• Report Number: 1828100-2015-00632
• 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: 07/14/2015

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: 500AVHCT
• Device Catalogue Number: 500AVHCT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2015
• Initial Date FDA Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2001
• 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