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

Model Number 06002-CP-110

Device Problem Volume Accuracy Problem (1675)

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

Event Date 09/28/2018

Event Type  malfunction  

Manufacturer Narrative

On november 8 2018, haemonetics was made aware of a collection procedure in which the device operator observed an instance of ac depletion, as the ac bag was found to be empty at the end of the procedure on (b)(6) 2018.Haemonetics has followed up with the customer for additional information regarding the donor's vitals, medical history, and their outcome following this incident.The customer has not indicated at this time that the donor experienced a citrate reaction, or if there were any medical interventions required.On november 19 2018, a haemonetics field service engineer evaluated the device and found that the pcs2 meets all manufacturer specifications and was unable to attribute this incident to a fault of the device.Despite no adverse reaction or injury to the donor and device operator, haemonetics has previously submitted a medwatch for incidents of ac depletion; as such, this incident is deemed reportable.

Event Description

On november 8 2018 haemonetics was made aware of an ac depletion incident which had occurred at the customer's collection center on (b)(6) 2018.The customer reported that they observed ac depletion at the end of the procedure, when the solution bag was found empty.At this time, the customer has not reported that the donor has experienced any adverse citrate reaction or an injury as a result of the ac depletion.

• Brand Name: PCS®2 PLASMA COLLECTION SYSTEM
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): HAEMONETICS CORPORATION; 400 wood road; braintree MA 02184
• Manufacturer (Section G): HAEMONETICS CORPORATION; 400 wood road; braintree MA 02184
• Manufacturer Contact: david ramsay ; 400 wood road; braintree, MA 02184
• MDR Report Key: 8197138
• MDR Text Key: 132075231
• Report Number: 1219343-2018-00070
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• 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: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/26/2018

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: Health Professional
• Device Model Number: 06002-CP-110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/1996
• 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