MAUDE Adverse Event Report: HAEMONETICS NEXSYS PCS INTERNATIONAL; NEXSYS PCS, INTERNATIONAL

Model Number PCS-300-INT

Device Problem Use of Device Problem (1670)

Patient Problem Discomfort (2330)

Event Date 06/30/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, haemonetics received information that a donor had a citrate reaction during a procedure using a pcs-300-int in (b)(6).The citrate bag was completely empty at end of donation.Process statistics showed consumption of 135 ml.The machine did not give any error messages regarding citrate consumption during donation and was set up correctly.Donor received 2x 500mg calcium oral + calciumgluconat fractionated i.V.During a running nacl infusion (4ml administered, from its 10 ml ampoule, where 10ml = 2.25mmol) mg of calcium iv.Donor felt better soon after and went home.

Manufacturer Narrative

The problem occurred post completion on the "procedure complete chart".It is suspected that the operator unloaded the ac pump and blood pump prior to disconnecting the donor or clamping the needle line.Investigation shows the equipment operated correctly and procedure performed as expected.The citrate reaction was caused by the manual infusion of the residual of ac to the donor due to operator errors post procedure.There were no nonconformances against the equipment serial number.There were no capas found related to this complaint.A review of the dhr shows no issues during manufacturing and all testing passed.Root cause was determined to be user error.No defect was found with the device.Donor was treated at the center, felt better soon after and went home.

• Brand Name: NEXSYS PCS INTERNATIONAL
• Type of Device: NEXSYS PCS, INTERNATIONAL
• Manufacturer (Section D): HAEMONETICS; 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: 15051569
• MDR Text Key: 296140002
• Report Number: 1219343-2022-00037
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: BK060033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PCS-300-INT
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2019
• 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