MCS?+ 8150 MULTICOMPONENT COLLECTION SYSTEM MCS+ (RBC),LIST NO 08150-110-E

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-18 for MCS?+ 8150 MULTICOMPONENT COLLECTION SYSTEM MCS+ (RBC),LIST NO 08150-110-E manufactured by Haemonetics Corporation.

Event Text Entries

[183889504] There was no patient involved in the incident. A field service engineer was dispatched to inspect the mcs+ 8150 machine, however the malfunction could not be determined on site. The machine will be returned to the manufacturing facility for further investigation.
Patient Sequence No: 1, Text Type: N, H10


[183889505] On (b)(6) 2020, haemonetics was informed by the customer of a device malfunction resulting in a burning smell.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1219343-2020-00021
MDR Report Key9847505
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-18
Date of Report2020-02-17
Date of Event2020-02-17
Date Mfgr Received2020-02-17
Device Manufacturer Date2016-03-31
Date Added to Maude2020-03-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR SHAUN FLANAGAN
Manufacturer Street125 SUMMER STREET
Manufacturer CityBOSTON, MA
Manufacturer CountryUS
Manufacturer G1HAEMONETICS CORPORATION
Manufacturer Street125 SUMMER STREET
Manufacturer CityBOSTON, MA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMCS?+ 8150 MULTICOMPONENT COLLECTION SYSTEM
Generic NameMCS+ 8150
Product CodeGKT
Date Received2020-03-18
Model NumberMCS+ (RBC),LIST NO 08150-110-E
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerHAEMONETICS CORPORATION
Manufacturer Address125 SUMMER STREET BOSTON, MA US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-18

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