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Adverse Event Report

ABBOTT LABORATORIES CUSTOM MONITORING KIT PRESSURE MONITORING KIT   back to search results
Catalog Number 46068
Event Type  Malfunction   Patient Outcome  Other;
Manufacturer Narrative

The unbonded connection areas were attached and detached with mating parts on several occasions with no problems observed. The kit was also examined for detached connectors with none found. Following visual evaluation, pressure was applied to the kit in order to detect any leaks. There were none observed. Co was unable to duplicate the problem experienced with the returned monitoring kit.

 
Event Description

The bonded joint between the zero stopcock and the pressure tubing failed during induction of the anesthesia on a pt undergoing carotid endarterectomy, resulting in a clotted off arterial line and severe hypotension which required treatment. The tracing on the a line was lost and the line could not be flushed. Pt recovered without sequelae. The incident occurred about mid june 1997.

 
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Brand NameCUSTOM MONITORING KIT
Type of DevicePRESSURE MONITORING KIT
Baseline Brand NameCUSTOM MONITORING KIT
Baseline Generic NamePRESSURE MONITORING KIT
Baseline Catalogue Number46068
Baseline Device FamilyMONITOR, BP, TRANSDUCER NON-INDWELLING
Baseline Device 510(K) NumberK831506
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed01/20/1997
Manufacturer (Section F)
ABBOTT LABORATORIES
4455 atherton
salt lake city UT 84123
Manufacturer (Section D)
ABBOTT LABORATORIES
4455 atherton
salt lake city UT 84123
Manufacturer (Section G)
ICU MEDICAL, INC
4455 atherton dr.
salt lake city UT 84123
Manufacturer Contact
david guzek
dept. 389, ap30
200 abbott park road
abbott park , IL 60064-3537
(847) 937 -3216
Device Event Key108794
MDR Report Key110777
Event Key104153
Report Number1713468-1997-00044
Device Sequence Number1
Product CodeDRS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/18/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/01/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number46068
Device LOT Number07-418-SN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/23/1997
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Ageunknown
Event Location Hospital
Date Manufacturer Received06/18/1997
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/1995
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

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