MAUDE Adverse Event Report: HAEMONETICS CORPORATION NEXSYS PLASMA COLLECTION SYSTEM; PCS300-US

Model Number PCS-300-US

Device Problem Insufficient Information (3190)

Patient Problems Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Incontinence (1928); Vomiting (2144); Convulsion/Seizure (4406)

Event Date 06/26/2023

Event Type  Injury  

Manufacturer Narrative

The collection center did not request a haemonetics field service engineer to inspect the pcs-300 collection system used during the collection procedure, which generally occurs if there are suspected issues with the collection device.The center and the donor did not suggest that the collection system did not operate as intended.A review of the device history record revealed no issues during the device manufacturing process that would contribute to this complaint.There were no non-conformance's related to the collection device serial number and no corrective actions/preventive actions related to this complaint.There is no evidence to suggest that the donor's adverse reaction was related to the collection device or collection disposables used during the collection procedure.

Event Description

Collection center reported to haemonetics on november 16, 2023, that a female donor had a severe reaction to sodium citrate during a plasmapheresis procedure.The end of procedure (eop) statistics from the collection system indicates that 1328 ml actual volume was collected (plasma and sodium citrate).However, the 1328 ml reading may not be accurate because haemonetics was informed the collection system was disturbed during the collection process.Haemonetics can not verify the actual amount collected because haemonetics does not have access to the collection sample bottle.The donor alleges that during the collection procedure she was given too much sodium citrate due to a collection center employee's error.However, the eop display indicates only 117 ml of sodium citrate was dispensed during the entire collection procedure, which is not an excessive amount.There was no report from the customer or donor that the collection device was defective.

• Brand Name: NEXSYS PLASMA COLLECTION SYSTEM
• Type of Device: PCS300-US
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer Contact: brenda bruyere ; 125 summer street; boston, MA 02110
• MDR Report Key: 18328243
• MDR Text Key: 330510391
• Report Number: 1219343-2023-00024
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK180185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/14/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: PCS-300-US
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2018
• 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
• Patient Outcome(s): Other
• Patient Sex: Female