Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HAEMONETICS CORPORATION NEXSYS PCS, US; PCS-300-US
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HAEMONETICS CORPORATION NEXSYS PCS, US; PCS-300-US Back to Search Results
Model Number PCS-300-US
Device Problem Smoking (1585)
Patient Problem No Patient Involvement (2645)
Event Date 02/11/2020
Event Type  malfunction  
Manufacturer Narrative
There was no patient involved in the incident.A field service engineer was dispatched and inspected the pcs-300 and noted that the pneumatics compressor connector burnt on the interconnect board and also a melted resister.The field service engineer will install new components and will run functional tests to verify that the machine is operating within manufacturing specifications.
 
Event Description
On (b)(6) 2020, haemonetics was informed by the customer of a device malfunction resulting in a burning smell and smoke.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NEXSYS PCS, US
Type of Device
PCS-300-US
Manufacturer (Section D)
HAEMONETICS CORPORATION
125 summer street
boston, ma
Manufacturer (Section G)
HAEMONETICS CORPORATION
125 summer street
boston, ma
Manufacturer Contact
shaun flanagan
125 summer street
boston, ma 
MDR Report Key9806168
MDR Text Key182567338
Report Number1219343-2020-00016
Device Sequence Number1
Product Code GKT
UDI-Device Identifier30812747011659
UDI-Public(01)30812747011659
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BK180185
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 02/11/2020
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 NumberPCS-300-US
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/11/2020
Initial Date FDA Received03/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/10/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-