MAUDE Adverse Event Report: HAEMONETICS, INC. PLS BUNDLED SET W/SALINE LINE; PLS BUNDLED SET W/SALINE LINE USED WITH NEXSYS PCS

Catalog Number 00783-00

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/26/2022

Event Type  Injury  

Manufacturer Narrative

A haemonetics field service engineer evaluated the nexsys pcs300 system used in the procedure.The system log files were downloaded, the device was fully tested and a water test was performed.There were no issues found with the equipment; testing showed no malfunction.The status of the disposables used in the procedure is unknown; without the samples, haemonetics is unable to perform further evaluation.

Event Description

On (b)(6), 2022, haemonetics was notified of the following during a donation procedure in belgium, utilizing a nexsys pcs 300 system: the injection went smoothly, samples were taken well.Smooth start of the purchase.After a few minutes an alarm came up on the screen that the plasma flow was not detected.No kinks in the line.Blood cells returned.Then always alarm that air was detected and collection stopped.During donation.Actions already taken.Decrease stopped.Donor slightly vagal, probably due to emotion, slight reaction to citrate, ca tablet given.

• Brand Name: PLS BUNDLED SET W/SALINE LINE
• Type of Device: PLS BUNDLED SET W/SALINE LINE USED WITH NEXSYS PCS
• Manufacturer (Section D): HAEMONETICS, INC.; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS, INC.; 125 summer street; boston MA 02110
• Manufacturer Contact: brenda bruyere ; 125 summer street; boston, MA 02110
• MDR Report Key: 13544019
• MDR Text Key: 285730476
• Report Number: 1219343-2022-00011
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: BK060033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/28/2022

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 Catalogue Number: 00783-00
• Device Lot Number: 8721125
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other