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

Model Number 06002-110-NA

Device Problems Nonstandard Device (1420); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2016

Event Type  malfunction  

Manufacturer Narrative

The customer returned the rotors for evaluation.The rotors were tested with a durometer and they were within specification.The center technician received new rotors and put the machine back in service.No root cause of the anticoagulant depletion was found.This issue of anticoagulant depletion has been investigated under a corrective action.The results of that investigation determined the likely cause was the harsh cleaning solution used to clean the pump rollers at the customer site can cause damage to the pump rollers which may lead to a device malfunction.Haemonetics confirmed that the customer is aware of the haemonetics medical device safety alert regarding the proper cleaning solutions to use to prevent the early degradation of the rotors.

Event Description

Haemonetics received a complaint on (b)(6) 2016 for a report of anticoagulant (ac) depletion with no donor reaction.

• 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: 6034447
• MDR Text Key: 57815663
• Report Number: 1219343-2016-00065
• Device Sequence Number: 0
• Product Code: GKT
• 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: Recall
• Type of Report: Initial
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 06002-110-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/22/2016
• Initial Date FDA Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2005
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: B-0349-2016
• Patient Sequence Number: 1