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

Model Number 06002-CP-110

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Tingling (2171)

Event Date 06/21/2016

Event Type  malfunction  

Manufacturer Narrative

Haemonetics has requested that the rotors be returned for evaluation.The rotors have not been returned.This issue of anticoagulant (ac) 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.New rotors were sent to the customer for the on-site technician to replace.It was confirmed with the customer that since receiving the haemonetics medical device safety alert they have been using the approved cleaning solutions on the pump rotors.They also confirmed that the new rotors were installed and there have been no further issues.Not returned.

Event Description

Haemonetics received a complaint on 06/23/2016 for a report that over the course of three days, there has been an issue with ac depletion in the pcs2, stating that the donor received too much anticoagulant; at the end of the procedure, the bag was empty and as a result the donor complained of a tingly sensation in mouth.After follow up with the customer there was no medical intervention given to the donor and the bag of anticoagulant appeared to have a lower amount of anticoagulant then usual but did not deplete.No other information was available.

• 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: 5769088
• MDR Text Key: 48748277
• Report Number: 1219343-2016-00046
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: BK920039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/23/2016

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?: Yes
• Device Operator: Phlebotomist
• Device Model Number: 06002-CP-110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2016
• Initial Date FDA Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/1997
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: B-0349-2016
• Patient Sequence Number: 1
• Patient Outcome(s): Other