MAUDE Adverse Event Report: HAEMONETICS CORP. PCS2 PLASMA COLLECTION SYSTEM

Catalog Number 06002-CP-110

Device Problems Fire (1245); Smoking (1585)

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

Event Date 07/07/2014

Event Type  malfunction  

Event Description

Haemonetics received a report on (b)(6) 2014 for a pcs2 device "machine started to smoke during procedure-evidence of fire on the power supply connector, backplane and boards in the card cage.No donor or operator injury reported.".

Manufacturer Narrative

A haemonetics field service engineer went to the center to evaluate the device.Ther was evidence of excessive burn marks within the device.The device could not be repaired in the field and no root cause of where the burning started from could be determined.The device is being returned to haemonetics for investigation and a supplemental report will be filed at that time.

• Brand Name: PCS2 PLASMA COLLECTION SYSTEM
• Manufacturer (Section D): HAEMONETICS CORP.; 400 wood rd.; braintree MA 02184
• Manufacturer Contact: julie smith, rn ; 400 wood rd.; braintree, MA 02184 ; 7819170643
• MDR Report Key: 4223747
• MDR Text Key: 16859681
• Report Number: 1219343-2014-00024
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK040025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/07/2014

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 06002-CP-110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2014
• Initial Date FDA Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/1996
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1