HEMOCHRON 8000 CTOR-A (H1005) *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-07-06 for HEMOCHRON 8000 CTOR-A (H1005) * manufactured by International Technidyne Corp.

Event Text Entries

[223548] Anticoagulation management of the cardiac surgery patient. In 11/99, heparin assay dosing was eliminated from the perfusion anticoagulation protocol by the cardiac cqi committee. Heparin is currently dosed at 300 u/kg or 400 units/kg to achieve a target act of 480 seconds. In january and february of 2001, the hemachron 8000 instruments were removed from svc and returned to the mfr for evaluation of "early and prolonged detection" values. Within the last 4 mos, clinical difficulties with the hemachron 8000 have been addressed, internally and externally, with the mfr. Initially, the occurrence of "early clot detection" (an act <80 secs) was thought to be the result of a quality control issue with the mfg of the act tube itself. Perfusion inventory was replaced with "spider" act tubes by the mfr in hopes of eliminating the occurrence of "early detection". In may of 2001, the mfr removed and replaced both hemachron 8000 instruments. In june of 2001, the frequency of early detection decreased slightly. However, difficulties with wide range variance and dosing with the rxdx program arose. Add'l concerns: accuracy of act values, add'l cost from duplication of tests, quality control of product, unexplained pt outcomes, accessibility of sales rep and responsiveness of mfr. Hemochron 8000 maintenance history: model # ctor-a (h1005). Purchased aug 1997. 9/26/97 - installed. 6/2/98 - would not boot - returned for svc. 12/10/00 - instrument aborting during testing - sent to mfr for svc. 12/18/00 - no problem found by mfr - placed into svc. 2/23/01 - wells not working, test aborting, button freezing - sent to mfr for svc, reprogram flash cards - returned 3/20/01. 3/27/01- experiencing early clot detect- spoke to mfr - will send new tubes, possible tube problems. 5/9/01 - still experiencing early detects - mfr to send replacement hemochron 8000. 5/22/01 - replacement sent back - buttons freezing. 6/1/01 - 2nd replacement received. Second device model # ctor-b (h1006). Purchased aug 1997. 9/26/97 - installed. 3/31/98 - printer broken - repaired. 3/01/01 - results are low and jumpy - sent to mfr, returned 4/16/01 - no problem found. 3/16/01 - loaner screen froze - returned for loaner replacement - received 3/22/01. 5/09/01 - mfr to send new replacement - housing was cracked upon receipt - sent back for another replacement. 5/29/01 - 2nd replacement received.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1022346
MDR Report Key341242
Date Received2001-07-06
Date Added to Maude2001-07-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameHEMOCHRON 8000
Generic Name*
Product CodeKQG
Date Received2001-07-06
Returned To Mfg2001-05-01
Model NumberCTOR-A (H1005)
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key330569
ManufacturerINTERNATIONAL TECHNIDYNE CORP
Manufacturer Address8 OLSEN AVE EDISON NJ 08820 US

Device Sequence Number: 2

Brand NameHEMOCHRON 8000
Generic Name*
Product CodeKQG
Date Received2001-07-06
Returned To Mfg2001-05-01
Model NumberCTOR-B (H1006)
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age*
Implant FlagN
Date Removed*
Device Sequence No2
Device Event Key330624
ManufacturerINTERNATIONAL TECHNIDYNE CORP.
Manufacturer Address8 OLSEN AVE EDISON NJ 08820 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2001-07-06

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