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

Model Number 06002-110-NA

Device Problems Smoking (1585); Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2018, haemonetics received a reported incident for a pcs®2 plasma collection system which had generated a spark and smoke when the back panel was removed from the machine by the center technician.Csl plasma reported that there were no injuries as a result of this incident, and there was no donor involvement with the device when the spark and smoke was observed.Haemonetics had the device evaluated by a field service engineer on (b)(6) 2018, the fse found that the spark and smoke were likely caused by the control distribution cable, which was shorted out.The fse was unable to determine what had caused the cable to short out, it is most likely due to a mechanical failure from wear and tear from removing and installing the rear panel on the device over time.The fse replaced the shorted cable, then proceeded to test the pcs®2 system parameters.The pcs®2 passed all safety tests, and the fse ensured that the device met all manufacturer specifications before returning the unit to service.

Event Description

On (b)(6) 2018, haemonetics was notified of a spark and smoke observed coming from the pcs®2 plasma collection system when the back panel was removed for maintenance.There was no donor involved in this incident.The technician was not injured as a result of the incident, no medical intervention was required.

• Brand Name: PCS®2 PLASMA COLLECTION SYSTEM
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): HAEMONETICS CORPORATION; 400 wood road; braintree MA 02184
• Manufacturer (Section G): HAEMONETICS CORPORATION; 400 wood road; braintree MA 02184
• Manufacturer Contact: david ramsay ; 400 wood road; braintree, MA 02184 ; 7813487327
• MDR Report Key: 7570474
• MDR Text Key: 110181205
• Report Number: 1219343-2018-00012
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK920039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 06002-110-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/1997
• 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