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

Model Number 06002-110-NA-EW

Device Problems Disconnection (1171); Difficult to Open or Close (2921)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 03/24/2014

Event Type  Injury  

Event Description

Haemonetics received a complaint on (b)(6) 2015 stating that a plasma center's employee reported that she strained her wrist when unlocking the centrifuge on the pcs®2 device.The employee's initial diagnosis in (b)(6) 2014 was for a wrist sprain, not otherwise specified.A later diagnosis was de quervain's tenosynovitis and epicondylitis of the elbow to a scaphoid lunate tear.This diagnosis led to surgical intervention with an extensor compartment release.The employee was on numerous work restrictions until being released from care on (b)(6) 2014.Haemonetics attempted to obtain additional information for this reported issue with no further information received.

Manufacturer Narrative

The customer could not provide a specific device serial number, however, provided a list of 18 possible devices that the employee was working on at the time.A haemonetics field service engineer completed a preventative maintenance check of each device on 06/09/2015.There were no issues found with the device cover locks.Haemonetics does not have evidence that there is a definitive causal relationship between the surgical intervention and the use of the device.

• 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: 4837596
• MDR Text Key: 5902245
• Report Number: 1219343-2015-00007
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Service and Testing Personnel
• Device Model Number: 06002-110-NA-EW
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/13/2015
• Initial Date FDA Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention