FDA Adverse Event Death Summary report: N

CARDINAL HEALTH AIRLIFE WATER TRAP

MDR report key: 952279 · Received November 16, 2007

Report

Report Number
952279
Event Type
Death
Date Received
November 16, 2007
Date of Event
November 11, 2007
Report Date
November 15, 2007
Manufacturer
CARDINAL HEALTH
Product Code
BYH
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Occupation
NOT APPLICABLE

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CARDINAL HEALTH AIRLIFE WATER TRAP WATER COLLECTION DEVICE FOR RESP. SYSTEM BYH CARDINAL HEALTH UNK

Patients

Seq Age Sex Outcome Treatment
1 89 YR Death 840 VENTILATOR GUI| FROM PT)| COVER (CANISTER CONTAINED 850 ML OF LIQUID)| LOT NUMBER: UNKNOWN| 840 VENTIL BREATH DELIVERY UNIT| COLLECTION JAR| CARDINAL HEALTH AIRLIFE H20 TRAP WITH 4 INCH FLEX| CONCHA THERM IIIL HUMIDIFIER| SUCTION CANISTER| IN-LINE NEBULIZER TEE WITH VALVE| LOT NUMBER: UNKNOWN| LOT NUMBER: UNKNOWN| CLOSED TRACHEAL SUCTION SUPPLIES| BIO MED| LOT # 7225225| (8 USED)| SAGE ORAL CARE SUCTION| SUCTION Y| CONCHA HUDSON RCI 1650 ML WATER (MAY NOT BE ORIG.| LOT #17079 11607| CONCHA STANDARD HUMIDIFIER COLUMN| TUBE (2 USED)| EXPIRATORY FILTER| VENTILATOR CIRCUIT| VENTILATOR BACK UP BATTERY| SUCTIONING SYSTEM PACK| LOT NUMBER: UNKNOWN| MEDI-VAC TUBING COONECTOR (2 USED)| BIO MED.| OHMEDA SUCTION REGULATOR| TUBING CONNECTOR 6 IN 1 Y| CON-MED. SIX FOOT SUCTION CONNECTION TUBING| OCR-A-FLEX II 22MM TUBING| BACTERIAL/VIRAL FILTER