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; NEXSYS PCS, 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; NEXSYS PCS, US Back to Search Results
Model Number PCS-300-US
Device Problem Calibration Problem (2890)
Patient Problem Hemolysis (1886)
Event Date 11/19/2020
Event Type  malfunction  
Manufacturer Narrative
Haemonetics field service engineer evaluated the nexsys plasma collection system, the weigher was out of spec.The unit was recalibrated and diagnostics checked, unit met specifications.
 
Event Description
On (b)(6) 2020, haemonetics was notified of a suspected hemolysis event utilizing the nexsys plasma collection system.Patient status is unknown as haemonetics was unable to obtain additional information from customer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NEXSYS PCS
Type of Device
NEXSYS PCS, US
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 Key11018681
MDR Text Key221764898
Report Number1219343-2020-00134
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 Biomedical Engineer
Type of Report Initial
Report Date 11/19/2020
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/19/2020
Initial Date FDA Received12/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-