MINNTECH, ACTRIL RESIDUAL TEST STRIPS 78258-000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-07-20 for MINNTECH, ACTRIL RESIDUAL TEST STRIPS 78258-000 manufactured by Minntech Corp.

Event Text Entries

[19035865] Eval was interviewing quality mgr and dialysis nurse mgr in 2007. Dialysis nurse mgr stated pt dialyzed in chronic dialysis unit, on the 2nd shift of pts, one month earlier. The dialyzer was from baxter and equipment used was a cobe c3 delivery system with gambro blood tubing. Pt complained of chest pain 2-1/2 hours into treatment. Treatment was discontinued and pt sent to er for eval. Pt was admitted to the hosp and chest pain attributed to hemolysis. The pt was successfully dialyzed in the hosp acute facility three days later, but expired one day later, after a cardiac arrest. Nurse mgr stated the c3 delivery system was disinfected with actril cold sterilant in the evening, five days earlier and the actril rinsed from the delivery system and removal verified using an actril residual test strip on the morning of the following day. Nurse mgr further reported, the container of actril residual test strips used during treatment were tested after pt was hospitalized using the qc protocol printed on the directions for use and found to be accurate and within acceptable standards. Facility turns on and rinses all delivery systems at the beginning of the treatment day, regardless of the scheduled first treatment for each machine. The c3 on which the pt dialyzed rinsed for approx 4-5 hours before pt was initiated on dialysis. Nurse mgr and dialysis biomed tech twice tested delivery system to verify residual actril levels at 5 and 18 minutes. Results: 5 min = all but small amount cleard, 18 min = rinsed free of actril to "0" ppm. Since pt began treatment on 2nd shift of pts, c3 had been rinsing at least 360 minutes prior to initiation of treatment. Mfr tested actril residual test strips from inventory and found strips to be within specification. Mfr believes test strips not a contributing factor.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2150060-2007-00006
MDR Report Key899207
Report Source05,06
Date Received2007-07-20
Date Mfgr Received2007-06-25
Device Manufacturer Date2007-02-01
Date Added to Maude2007-08-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location0
Manufacturer Street14605 28TH AVE N
Manufacturer CityMINNEAPOLIS MN 55447
Manufacturer CountryUS
Manufacturer Postal55447
Manufacturer Phone7635533300
Manufacturer G1MINNTECH CORP
Manufacturer Street14605 28TH AVE N
Manufacturer CityMINNEAPOLIS MN 55447
Manufacturer CountryUS
Manufacturer Postal Code55447
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMINNTECH, ACTRIL RESIDUAL TEST STRIPS
Generic NameACTRIL RESIDUAL TEST STRIPS
Product CodeMSY
Date Received2007-07-20
Catalog Number78258-000
Lot NumberTA705579
Device Expiration Date2008-07-01
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key853482
ManufacturerMINNTECH CORP
Manufacturer Address14605 28TH AVE N MINNEAPOLIS MN 55447 US


Patients

Patient NumberTreatmentOutcomeDate
10 2007-07-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.