MAUDE Adverse Event Report: HAEMONETICS CORPORATION NEXSYS PCS SYSTEM; NEXSYS PCS SYSTEM D2 NEXSYS PCS, US, PRODUCT CODE: GKT

Model Number PCS-300-US

Device Problems Thermal Decomposition of Device (1071); Temperature Problem (3022)

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

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

This report is being sent as part of a service record retrospective review that was self identified by haemonetics.The following parts were sent to customer biomed for repair: power supply, sl power, rohs.The suspect device/part was not returned to haemonetics, without physical sample provided for evaluation, the root cause cannot be determined.

Event Description

Haemonetics was notified by a customer that a condor had a burnt issue.There was no donor involvement.

• Brand Name: NEXSYS PCS SYSTEM
• Type of Device: NEXSYS PCS SYSTEM D2 NEXSYS PCS, US, PRODUCT CODE: GKT
• 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: 11812243
• MDR Text Key: 250205018
• Report Number: 1219343-2021-00054
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 30812747011659
• UDI-Public: (01)30812747011659
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/28/2019

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: PCS-300-US
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2016
• 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