VENTRICULAR CATHETER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-04-11 for VENTRICULAR CATHETER manufactured by Unk.

Event Text Entries

[17714] Pt was admitted to hosp on 2/14/96 for an intracranial hemorrhage and had a ventriculostomy tube placed. Nurse administered kefzol at approx 6:20 am on 2/18/96, which was ordered as a prophylactic antibiotic. Instead of administering the kefzol intravenously, as ordered, the nurse injected the kefzol into the ventriculostomy tubing. At 7:00 am, the day shift began. The charge nurse for the night shift and the primary nurse for this pt advised the day shift charge nurse that she had been experiencing nausea and vomiting. At approx 7:05 am, a nurse entered the pt's room to administer the anti-emetic medication as ordered, ondancetron. At that time, it was discovered that the piggyback iv line had been connected to the ventriculostomy tubing. This was corrected and the ondancetron was administered through the peripheral line. Dr of neurosurgery, was notified of the incident immediately. The pt continued to complain of nausea and headache, but the emesis stopped. The pt displayed anxiety and was shaking. Ativan 1 mg iv was administered at 7:45 am. The pt proceeded to become more anxious and started to hallucinate. Haldol. 25 mg im was given at 8:55 am. At this time, dr entered the room and ordered the pt to be transferred to the sicu for closer observation. The pt continued with hallucinations and screaming aloud. Prior to the pt leaving for the sicu, ativan 2 mg iv was administered at 9:30. Dilantin 500 mg iv was ordered and started on the pt at 9:45 am, immediately prior to pt leaving unit 65. Just before reaching the sicu, the pt coded and was asystolic for approximately 10 minutes. Life support was begun; however, subsequent scan findings met the criteria for brain death. Life support was terminated and the pt expired 2/19/96 at approximately 8:00 pm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number31397
MDR Report Key31397
Date Received1996-02-23
Date of Report1996-02-21
Date of Event1996-02-18
Date Facility Aware1996-02-18
Report Date1996-02-21
Date Added to Maude1996-03-27
Event Key0
Report Source CodeUser Facility 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 FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameVENTRICULAR CATHETER
Generic NameVENTRICULAR CATHETER
Product CodeHCD
Date Received1996-04-11
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Age*
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key32516
ManufacturerUNK
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
101. Death 1996-02-23

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