HEMOCHRON RESPONSE COAGULATION SYSTEM HRS.220

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2010-04-07 for HEMOCHRON RESPONSE COAGULATION SYSTEM HRS.220 manufactured by International Technidyne Corp..

Event Text Entries

[17061435] Health care professional: reports the blood clotting time between the two test wells for hemochron response had a difference of over 60 seconds although the doctor used the sample blood sample per customer. Poor pt correlation. Pt was being monitored while on bypass, the targeted range for the pt was -350 sec.
Patient Sequence No: 1, Text Type: D, B5


[17235867] (b)(4). Manufacturer awaiting medical device return from customer for eval.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2248721-2010-00067
MDR Report Key1657237
Report Source05,08
Date Received2010-04-07
Date of Report2010-04-07
Date Mfgr Received2010-03-10
Date Added to Maude2010-11-05
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 FDA0
Event Location0
Manufacturer ContactLAWRENCE PICCIANO
Manufacturer Street8 OLSEN AVE.
Manufacturer CityEDISON NJ 08820
Manufacturer CountryUS
Manufacturer Postal08820
Manufacturer Phone7325485700
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEMOCHRON RESPONSE COAGULATION SYSTEM
Generic NameHEMOCHRON RESPONSE COAGULATION ANALYZER
Product CodeKQG
Date Received2010-04-07
Model NumberHRS.220
Catalog NumberHRS.220
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINTERNATIONAL TECHNIDYNE CORP.
Manufacturer AddressEDISON NJ 08820 US 08820


Patients

Patient NumberTreatmentOutcomeDate
10 2010-04-07

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