MAUDE Adverse Event Report: HAEMONETICS CORP MCS® + 8150; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

Model Number 08150-110-E

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2016

Event Type  malfunction  

Manufacturer Narrative

Haemonetics field service engineer (fse) evaluated the device.There was no malfunction of the device.The rotors were tested with a durometer and they were within specification, but the fse replaced as a precautionary measure.The device was put back into use.No root cause of the saline depletion was found.This issue of saline and 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.

Event Description

Haemonetics received a complaint on (b)(6) 2016 for a report of w68 (air detected early check saline bag) ran out of saline at the end of return.There was no report of any donor injury or reaction.

• Brand Name: MCS® + 8150
• 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: 5967056
• MDR Text Key: 55269888
• Report Number: 1219343-2016-00062
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK090004
• 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: 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 08150-110-E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2016
• Initial Date FDA Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2008
• 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-0347-2016
• Patient Sequence Number: 1