CARDINAL HEALTH AIRLIFE WATER TRAP 5276

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2007-11-16 for CARDINAL HEALTH AIRLIFE WATER TRAP 5276 manufactured by Cardinal Health.

Event Text Entries

[738780] A male admitted in 2007 with respiratory failure secondary to recurrent aspiration pneumonia, septic shock, end stage renal disease requiring hemodialysis, hypotension, cad status post cabg, severe pvd, chf, and rapid a. Fib with rapid ventricular response. Patient was intubated in the emergency department with a chest x-ray showing right lower lobe infiltrate. The pt underwent bronchoscopy on the same day, with removal of large amounts of secretion. Patient is an dnr. A week later, patient condition continues to worsen. Patient is positive mrsa. Echocardiogram shows severe left ventricular dysfunction with an ejection fraction of 10%, aortic stenosis, mod/severe mitral regurgitation. Bp ranges from 80-90 systolic on multiple pressers prognosis poor. At 0415 on that day, pt was given bed bath and total linen change. At 0445, rn in room preparing tube feeding, ventilator alarmed severe occlusion, rn attended to alarm immediately, rn noted clamp on water trap connected to expiratory line of ventilator to be in the open position (normally would have been closed). Register nurse exanimated ventilatory tubing and found inspiratory tubing to be filled with water. Patient was removed from ventilator and was bagged. Patient was suctioned returning copious amount of water. Patient was found to be in pea confirmed on ultrasound and pronounced dead.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number952279
MDR Report Key952279
Report Source99
Date Received2007-11-16
Date of Report2007-11-15
Date of Event2007-11-11
Date Facility Aware2007-11-11
Report Date2007-11-15
Date Reported to FDA2007-11-15
Date Reported to Mfgr2007-11-15
Date Added to Maude2007-11-28
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCARDINAL HEALTH AIRLIFE WATER TRAP
Generic NameWATER COLLECTION DEVICE FOR RESP. SYSTEM
Product CodeBYH
Date Received2007-11-16
Catalog Number5276
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key923960
ManufacturerCARDINAL HEALTH
Manufacturer AddressMCGAW PARK IL 60085 US


Patients

Patient NumberTreatmentOutcomeDate
18401. Death 2007-11-16

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