MAUDE Adverse Event Report: HAEMONETICS CORP PCS®2 PLASMA COLLECTION SYSTEM; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

Model Number 06002-110-EXP-EW

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2017

Event Type  malfunction  

Manufacturer Narrative

The left bottom air filter on the device caught on fire due to a spark between the cabinet and the frayed power cord.The power cord was not sent with the device.The fire was due to a frayed power cord, which was a result from the center utilizing a setup that facilitated power cord damage - power cords constantly getting between two moving parts and thus damaged.The device was on a rotating surface which allowed for the power cord to be caught under the device and get severely worn with wires exposed as the device is being rotated.There were no device anomalies found from manufacturing that may have contributed to the reported issue.A haemonetics representative went to the customer site and confirmed the setup that is being utilized.

Event Description

Haemonetics received a call on (b)(6) 2017 stating that the pcs®2 plasma collection system machine caught fire when the power cord was twisted under machine and frayed, causing the bottom filter to catch fire and escalate to the inside and outside of the machine.No injuries involved.

• Brand Name: PCS®2 PLASMA COLLECTION SYSTEM
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): HAEMONETICS CORP; 400 wood rd; braintree MA 02184
• Manufacturer (Section G): HAEMONETICS CORP; 400 wood rd; braintree MA 02184
• Manufacturer Contact: julie smith, rn ; 400 wood rd; braintree, MA 02184 ; 7819170643
• MDR Report Key: 6439120
• MDR Text Key: 71261049
• Report Number: 1219343-2017-00008
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK060033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Phlebotomist
• Type of Report: Initial
• Report Date: 02/27/2017

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: No Information
• Device Model Number: 06002-110-EXP-EW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2017
• Initial Date FDA Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2013
• 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