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

Catalog Number 06002-110-NA-EW

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2014

Event Type  malfunction  

Event Description

Haemonetics received a report on 01/31/2014 for a pcs2 device "tech stated machine caught on fire at the power entry module connection.Donor was on bed when this happened.Donor was disconnected and was not harmed.Machine fire went out immediately when cord was unplugged from wall.".

Manufacturer Narrative

The field service technician evaluated the device at the customer location.White residue was found on the power entry module, rotors, and power cord.This white residue is common when anticoagulation (ac) solution spillage is occurring around the machine.Smoke stains were found around the power entry module.Ac solution leakage made contact where the power cord and power entry module meet, causing sparks to ignite.The sparks immediately extinguished when the power cord was unplugged.The power entry module and the power cord was unplugged.The power entry module and the power cord were the only parts damaged.They were replaced with new parts, the pcs2 powered on correctly.A full diagnostics check was run, and all voltages were confirmed in range.The power entry module and power cord are being returned for further evaluation.A supplemental report will be filed when the evaluation results are completed.This device did undergo preventative maintenance within the last year and met all manufacturer specifications and all leakage current was within the acceptable range.This device meets iec 601-1 electrical standards.There is no history with this device catching fire at the power entry module.(b)(4).

• 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 ; 7814367209
• MDR Report Key: 3916482
• MDR Text Key: 4588191
• Report Number: 1219343-2014-00009
• 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: 01/31/2014

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 Catalogue Number: 06002-110-NA-EW
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/04/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2014
• Initial Date FDA Received: 02/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2008
• 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