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

Model Number 500AVHCT

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Not Applicable (3189)

Event Date 03/20/2014

Event Type  malfunction  

Event Description

The subsidiary service repair technician (srt) reported that during routine testing of the device at the subsidiary's mfg engineering center (mec), the blood parameter monitor (bpm) display failed.One line was displayed from top to bottom on the screen, but was still readable.There was no pt involvement.

Manufacturer Narrative

Per the laboratory eval, the technician observed that the pink wire from the output of the liquid crystal display (lcd) driver printed circuit board assembly (pcba) has two nicks in it.This may cause display issues if it is shorted to chassis ground or other points of ground as these lines have approx 330 volts a/c on them going to the display.The blood parameter monitor (bpm) passed startup self-diagnostics with no errors observed, and no line from top to bottom observed per the reported complaint.

• 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 ; 7346634145
• MDR Report Key: 3943770
• MDR Text Key: 4641222
• Report Number: 1828100-2014-00364
• 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: 04/16/2014

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: 500AVHCT
• Device Catalogue Number: 500AVHCT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/31/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/16/2014
• Initial Date FDA Received: 04/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2003
• 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