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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HAEMONETICS CORPORATION PCS2 PLASMA COLLECTION SYSTEM; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
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HAEMONETICS CORPORATION PCS2 PLASMA COLLECTION SYSTEM; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC Back to Search Results
Model Number 06002-CP-110
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Patient Involvement (2645)
Event Date 10/31/2019
Event Type  malfunction  
Manufacturer Narrative
On (b)(6) 2019 haemonetics received a reported complaint for a pcs2 machine which was observed to have a burning smell during the power on self test.Alpha source reported that the on-site technician replaced the fuses in the unit, when they powered on the device they observed a burning smell and removed the device from service.Haemonetics has sent a replacement a replacement device to alpha source as resolution.There was no report of injury as a result of the burning smell observed with no report of visible smoke, electrical arcing or fire.The failure of this component will prevent the device from passing the power on self test, which eliminates the risk of injury to a donor.There were no injuries reported as a result of this incident, however haemonetics has previously submitted reports of thermal decomposition observed within a device, as a result this incident is deemed reportable.
 
Event Description
On (b)(6) 2019 haemonetics received a reported complaint for a pcs2 machine which was observed to have a burning smell during the power on self test.Alpha source reported that the on-site technician replaced the fuses in the unit, when they powered on the device they observed a burning smell and removed the device from service.Haemonetics has sent a replacement a replacement device to alpha source as resolution.There was no report of injury as a result of the burning smell observed with no report of visible smoke, electrical arcing or fire.The failure of this component will prevent the device from passing the power on self test, which eliminates the risk of injury to a donor.
 
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Brand Name
PCS2 PLASMA COLLECTION SYSTEM
Type of Device
SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
Manufacturer (Section D)
HAEMONETICS CORPORATION
125 summer street
boston MA 02111
Manufacturer (Section G)
HAEMONETICS CORPORATION
125 summer street
boston MA 02111
Manufacturer Contact
david ramsay
125 summer street
boston, MA 02111
7813487327
MDR Report Key9379088
MDR Text Key168096859
Report Number1219343-2019-00064
Device Sequence Number1
Product Code GKT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BK920039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Non-Healthcare Professional
Remedial Action Replace
Type of Report Initial
Report Date 11/26/2019
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 Other
Device Model Number06002-CP-110
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/31/2019
Initial Date Manufacturer Received 10/31/2019
Initial Date FDA Received11/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/1997
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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