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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HAEMONETICS CORPORATION NEXSYS PCS; NEXSYS PCS, US
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HAEMONETICS CORPORATION NEXSYS PCS; NEXSYS PCS, US Back to Search Results
Model Number PCS-300-US
Device Problem Smoking (1585)
Patient Problem No Patient Involvement (2645)
Event Date 08/19/2020
Event Type  malfunction  
Manufacturer Narrative
There was no patient involved in the incident.The device was returned to depot repair where it was evaluated and serviced.Based on evaluation the pneumatic compressor was overheated and cable connector was burnt on the nexsys pcs system.The pneumatic compressor was replaced and the device was operating within manufacturing specifications.
 
Event Description
On (b)(6) 2020 haemonetics was notified of smoke and burning smell from the nexsys pcs system.
 
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Brand Name
NEXSYS PCS
Type of Device
NEXSYS PCS, US
Manufacturer (Section D)
HAEMONETICS CORPORATION
125 summer street
boston, ma
Manufacturer (Section G)
HAEMONETICS CORPORATION
125 summer street
boston, ma
Manufacturer Contact
janice kiser
125 summer street
boston, ma 
MDR Report Key10454792
MDR Text Key204391694
Report Number1219343-2020-00082
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 08/19/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2020
Initial Date Manufacturer Received 08/19/2020
Initial Date FDA Received08/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/15/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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