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 1994-09-12 for DRAKE WILLOCK 4009-1 manufactured by Althin Cd Medical, Inc..

Event Text Entries

[19139260] Dialysis facility operates 2 central delivery systems during the day shift. Only one central needed on evening shift. At 6:00 pm while 6 pts were dialyzing, the wrong central delivery system was placed in the rinse mode. The 6 pts dialyzed against acid concentrate and water for approximately 3 minutes. The pts complained of severe cramping and chest pains. Mistake realized. System placed in bypass. All treatments terminated. Blood returned. Treatments resumed after central placed back in correct mode and conductivity came into range. Treatment restarted at 6:30 pm on one pt. Bp 144/64. Pt complained of nausea at 6:50 pm. Reglan 5 mg given iv, bp 124/62, blood sugar 120, oxygen initiated at 2 l/min. Bp 162/62 and 170/64 upon 1/2 hr checks. Pt seen by physician at approximately 8:00 pm. At 8:10, pt still complaining of nausea after treatment terminated (8:05) second dose of reglan 5 mg iv given. Pt instructed that nausea was likely caused by dialysis with a bath of low conductivity and to avoid high potassium foods. Pt also instructed to call physician if nausea worsened or new symptoms developed. Upon returning home, pt complained of chills and nausea. Took an antiemetic suppository and went to bed. Several hrs later, pt's husband found pt without pulse or respirations, and called rescue squad. Rescue squad unable to revive pt. Four of the six other pts dialyzed the next day. 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 medical conditions. Correlation believed to be unlikely, but could not definitely be ruled out.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number17044
MDR Report Key17044
Date Received1994-09-12
Date of Report1994-09-12
Date of Event1994-09-07
Date Facility Aware1994-09-08
Report Date1994-09-12
Date Reported to FDA1994-09-12
Date Added to Maude1994-10-24
Event Key0
Report Source CodeUser Facility 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 DELIVER SYSTEM-DIALYSIS
Product CodeFKQ
Date Received1994-09-12
Model Number4009-1
OperatorOTHER
Device AvailabilityY
Device Age14 YR
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key16977
ManufacturerALTHIN CD MEDICAL, INC.
Manufacturer AddressPORTLAND OR 97222 US


Patients

Patient NumberTreatmentOutcomeDate
101. Death 1994-09-12

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