MAUDE Adverse Event Report: HAEMONETICS CORP MCS®+ 9000 MOBILE PLATELET COLLECTION SYSTEM; SEPERATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

Model Number 09000-220-E

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/14/2017

Event Type  malfunction  

Manufacturer Narrative

The haemonetics field service engineer evaluated the device.The rotors were tested with a durometer and they were within specification.The engineer replaced the rotors as a precautionary measure and put the machine back in service.No root cause of the anticoagulant overconsumption 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.Haemoentics 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) 2017 on the mcs® + 9000.The customer reported an overconsumption of anticoagulant solution (ac) with no donor reaction.

• Brand Name: MCS®+ 9000 MOBILE PLATELET COLLECTION SYSTEM
• Type of Device: SEPERATOR, 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: 6375727
• MDR Text Key: 69344731
• Report Number: 1219343-2017-00004
• Device Sequence Number: 0
• Product Code: GKT
• Reporter Country Code: IT
• PMA/PMN Number: BK080038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Phlebotomist
• Device Model Number: 09000-220-E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2017
• Initial Date FDA Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2006
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: B-0348-2016
• Patient Sequence Number: 1