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

Model Number 06002-CP-220

Device Problem Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

The haemonetics engineer inspected the machine october 16 2020 and identified the ac pump rollers were dirty and out of specifications regarding the hardness (service report # (b)(4)).The rollers have been changed and the machine is within the specifications and back in use.

Event Description

On (b)(6) 2020 haemonetics was notified of an empty citrate bag which was observed post procedure in (b)(6), utilizing nexsys pcs system.The machine displayed a citrate consumption of 148ml although the citrate bag was empty.There was no reported impact to patients' health.

• Brand Name: NEXSYS PCS
• Type of Device: NEXSYS PCS, INTERNATIONAL
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer Contact: janice kiser ; 125 summer street; boston, MA 02110
• MDR Report Key: 10843760
• MDR Text Key: 218962461
• Report Number: 1219343-2020-00109
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 30812747011741
• UDI-Public: (01)30812747011741
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: BK180185
• 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: 10/16/2020

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-220
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/1997
• 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