DRAKE WILLOCK 4009-1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-26 for DRAKE WILLOCK 4009-1 manufactured by Althin Cd Medical, Inc..

Event Text Entries

[11543] Dialysis facility operates and control delivery systems during the day shift. Only one central needed on evening shift. At 6 pm while six pts were dialyzing, the wrong vcentral was placed in te mode/ the six pts dialyzed against acid concentrate and ro water for approx. Three minutes. The pts complained of severe cramping and chest pains. Mistake realized. System placed in bypass. All treatments terminated. Blood returned. Treatments after central placed back in correct mode and conductiviy came into range. Treatment restarted at 6:30 pm onatient s. C. Bp 144/64. Pt complained of nausea at 6:50 pm. Reflan 5mg given iv. Bp 124/62. Blood sugar 120, oxygen initiated at 2l/min. Bp 162/62 and 170/64 upon 1/2 hr checks. Pt seen by physianatapprox 8 pm. At 8:10 pt still complaining of nausea after treatment terminated (8:05) second dose of reflan 5mg iv given. Pt instructed that nausea was likely caused by dialysis with a batch of low conductivity and to avoid high potassium foods. Pt also instructed to call physician if nausea worsened or new symptoms developed. Upon returing hoe, pt complained of chills and nausea, took an antiemetric suppository and went tobed. Several hhrs later, pt's husband found pt without pulse or respiration and called rescue. Rescue unable to revive pt. Four of the six other pts dialyzed the next daay. None of the other pts experienced permanent injury. Human error determined as cause for incident not device failure. Physician unsure if event contributed to pt's death since pt had multiple conditions. Crelation believed to be unlikely, but could not definitely be ruled out.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2243621-1994-00401
MDR Report Key18858
Date Received1994-10-26
Date of Report1994-09-12
Date of Event1994-09-07
Date Facility Aware1994-09-14
Report Date1994-09-27
Date Reported to FDA1994-09-27
Date Reported to Mfgr1994-09-27
Date Added to Maude1995-01-09
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDRAKE WILLOCK
Generic NameCENTRAL DELIVERY SYSTEM - DIALS
Product CodeFKQ
Date Received1994-10-26
Model Number4009-1
OperatorOTHER
Device AvailabilityY
Device Age14 YR
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key16977
ManufacturerALTHIN CD MEDICAL, INC.
Manufacturer AddressDRAKE WILLOCK DIVISION 13520 SE PHEASANT COURT PORTLAND OR 97222 US


Patients

Patient NumberTreatmentOutcomeDate
101. Death 1994-10-26

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