FDA Adverse Event Injury Summary report: N

STRATUS 5

MDR report key: 21297862 · Received January 31, 2025

Report

Report Number
MW5165577
Event Type
Injury
Date Received
January 31, 2025
Date of Event
January 17, 2025
Report Date
January 28, 2025
Manufacturer
3B MEDICAL INC
Product Code
CAW
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
GA, US
Reporter Occupation
UNKNOWN
Health Professional
*

Narratives

Description of Event or Problem · 0

A 78-YEAR-OLD FEMALE PATIENT (PT) WAS DIRECTLY ADMITTED TO (B)(6) HOSPITAL, PER HEART FAILURE SPECIALIST, WHERE PT RECEIVED INPATIENT CARE IN CARDIOLOGY UNIT AND WAS DISCHARGED ON (B)(6)2025. PT WAS DISCHARGED WITH IMPROVED CONDITION, SWELLING GONE FROM FEET AND ANKLES, AND WAS OBSERVED TO MOVE AROUND WITHOUT PREVIOUS LEVEL OF EXERTION. ORDERS FOR DME (DURABLE MEDICAL EQUIPMENT) WERE SENT FOR PT TO RECEIVE 2ML OXYGEN FOR USE AS NEEDED DURING MOVEMENT AT HOME. PT WAS REFUSED DISCHARGE PAPERWORK UNTIL (B)(6) AND (B)(6) CORRESPONDED FOR INSURANCE COVERAGE OF 02, AND (B)(6) RECEIVED PAYMENT INFORMATION FROM PT VIA PHONE CALL. (PT AND FAMILY MEMBER WERE INFORMED BY AN ATTENDING PATIENT MED TECH THE PREVIOUS NIGHT THAT THE HOSPITAL WOULD NOT LET HER LEAVE UNTIL OXYGEN WAS DELIVERED TO HER HOUSE.) ON DATE OF DISCHARGE PT WAS MADE TO STAY ON HOSPITAL PREMISES UNTIL AEROCARE VENDOR CALLED PT'S CELL PHONE FOR CREDIT CARD AS FUTURE PAYMENT INFORMATION, SCHEDULING OF DELIVERY FOR TANKS AND CONCENTRATOR TO THE PT'S HOME ADDRESS FOR THAT EVENING, AND DISPATCH OF THE AEROCARE REPRESENTATIVE THAT DELIVERED A SINGLE O2 TANK TO THE PT'S HOSPITAL ROOM. THAT EVENING ADAPTHEALTH DELIVERED SEVERAL LARGE 02 TANKS, 2 HOSES, AND AN 02 CONCENTRATOR THE COMPANY REP INDICATED AS A NEW MACHINE. (THE CONCENTRATOR IS LABELED 3B MEDICAL INC; STRATUS 5; STR1005, ETC.). THE PT ADHERED TO DISCHARGE INSTRUCTIONS, USING THE 02 CONCENTRATOR WHILE MOVING AROUND ONLY AS NEEDED. ON (B)(6) 2025 PT VISITED PCP (PRIMARY CARE PROVIDER) FOR FOLLOW-UP WHERE DIAGNOSTICS WERE PERFORMED (BLOOD WORK, X-RAY OF LUNGS, ETC.). PER PCP X-RAY RESULTS PT'S HEART AND LUNGS APPEARED WITHOUT NOTABLE FINDINGS. PT'S MEDS WERE CHANGED AND ADJUSTED. (BLOOD WORK SHOWED ABNORMALITIES.) A SMALLER PORTABLE OXYGEN TANK WAS ORDERED FROM AWROCARE/ADAPTHEALTH. ADAPTHEALTH DELIVERED SMALL PORTABLE MACHINE, RETRIEVED ALL LARGE 02 RANKS EXCEPT FOR ONE, AND LEFT 3B MEDICAL INC 02 CONCENTRATOR MACHINE FOR CONTINUED USE. PT RETUNED HOME, ADHERED TO INSTRUCTIONS, AND WITHIN 4 DAYS EXPERIENCED RECURRING SWELLING OF FEET AND ANKLES OCCURRING WITH DECREASED URINATION. PT. ALSO EXPERIENCED WORSENING SYMPTOMS WITH INCREASED USE OF 3B MEDICAL INC STRATUS 5 02 CONCENTRATOR NOT LIMITED TO DRY MOUTH, SINUS PRESSURE, NOSE BLEEDS, LOWER ENERGY LEVEL, DECREASED ABILITY TO SLEEP, AND BY (B)(6) 2025 AROUND 0437 EST PT CALLED OUT FOR FAMILY MEMBER DUE TO INABILITY TO BREATHE. PT TOOK FAST ACTING INHALER AND REMAINED ON 02 CONCENTRATOR UNTIL FOLLOW-UP WITH PCP OCCURRING THAT DAY AS PER CORRESPONDENCE WITH CARE TEAM. PRIOR TO FOLLOW UP REPORTED SYMPTOMS TO PCP AND SPECIALISTS, REQUESTING URGENT GUIDANCE, AND FOR PT CARE TEAM TO PERFORM COMPREHENSIVE MEDICATION REVIEW WITH CONSIDERATION OF DIAGNOSTIC RESULTS, NOTABLE TRENDS CORRESPONDING TO NEW MEDICATIONS, AND AGAINST AGS PUBLISHED WORKS INCLUDING BEERS CRITERIA. DURING FOLLOW-UP APPOINTMENT WITH PCP ON (B)(6) 2025, ANOTHER X-RAY WAS PERFORMED. PER PCP RESULT READING PT'S LUNGS APPEARED TO WORSEN AND SHOWED PRESENCE OF FLUID, EDEMA IN FEET AND ANKLES OBSERVED AS RETURNED WITH DECREASED URINATION. PCP INFORMED PT AND FAMILY TO TAKE PT TO ED DUE TO X-RAY RESULTS. THE ED PERFORMED DIAGNOSTICS NOT LIMITED TO ANOTHER X-RAY, CT (COMPUTED TOMOGRAPHY), AND BLOOD WORK. THE ED IDENTIFIED PLEURAL EFFUSION AND RESULTS INDICATING ENLARGED HEART. THE PT WAS ADMINISTERED OXYGEN, BREATHING TREATMENT, AND IV LASIX. PT WAS ABLE TO URINATE WHILE AT ED POST IV LASIK, CONVEYED FEELING BETTER, AND EXHIBITED COLOR RETURNED TO NORMAL. PT WAS DISCHARGED, RETURNED HOME WHERE 02 CONCENTRATOR MACHINE WAS USED AS PER INSTRUCTED. BY (B)(6) 2025 THE PT HAS EXPERIENCED DECREASE IN URINATION RECURRING WITH SWELLING OF FEET AND ANKLES. NOSE BLEEDS RECURRED WITH MORE BLOODY DISCHARGE UPON PRESCRIBED USE OF MEDLINE BREATHING TREATMENT MACHINE AND 3B MEDICAL INC 02 MACHINE AND HOSE. PLEASE CONTACT FOR ADDITIONAL DETAILS. THE PT'S FAMILY IS CONCERNED ABOUT KIDNEY FUNCTION DUE TO TEST RESULTS AND SYMPTOMS OCCURRING AFTER PT'S HEART HEALTHCARE WAS TAKEN OVER BY HEART SPECIALISTS WORKING WITH PT'S HEART DOCTOR AT THE RECOMMENDATION OF THE SPECIALIST THAT PRESCRIBED MEDICATIONS ENTRESTO AND JARDIANCE. PER JARDIANCE MANUFACTURER, ASSESSING KIDNEY FUNCTION AND TESTING ARE RECOMMENDED BEFORE PRESCRIBING THIS MEDICATION FOR HEART FAILURE PATIENTS. THE PT RECORDS DO NOT SHOW THIS TESTING WAS PERFORMED. NOTE THE PT HAD NO HISTORY OF DIABETES, ABNORMAL GFR (GLOMERULAR FILTRATION RATE,), CREATINE, BUNION, AND TRENDING HIGH GLUCOSE LEVELS UNTIL TAKING JARDIANCE AND ENTRESTO COMBINATION. REQUESTED PTS PHARMACIST, PCP, AND HMO OPTUM RX PERFORM COMPREHENSIVE MEDICATION REVIEW, AS PER (B)(6) GUIDELINES, MORE THAN A YEAR AGO WHEN THE FIRST LAB WORK RESULTS WERE BACK FROM TESTING DONE 7 DAYS AFTER THE PT WAS PRESCRIBED THIS COMBO. THE EARLIER RESULTS INDICATED A DECREASE IN KIDNEY FUNCTION AND INCREASE IN GLUCOSE LEVELS WHEREAS MED RECORDS DO NOT INDICATE THESE TEST RESULTS OR BASELINE WAS ESTABLISHED FOR REFERENCE PRIOR TO THE JARDIANCE AND ENTRESTO BEING PRESCRIBED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
631892 STRATUS 5 GENERATOR, OXYGEN, PORTABLE CAW 3B MEDICAL INC STR1005

Patients

Seq Age Sex Outcome Treatment
1 78 YR Female Hospitalization| O| R