SUNSET BRAND OXYGEN TUBING 7 FT WITH NASAL CANNULA RES3007

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-17 for SUNSET BRAND OXYGEN TUBING 7 FT WITH NASAL CANNULA RES3007 manufactured by Sunset Healthcare Solutions.

Event Text Entries

[114541553] Problem started when dme provider switched from name brand oxygen tubing to sunset brand (res3007 - 7ft oxygen tubing with nasal cannula and res3050 - 50ft oxygen tubing), for oxygen-dependent patient compliant with o2 and cpap, res3050 kept popping off oxygen concentrator at random times of day and night. At (the) same time, patient was becoming more lethargic and feeble. This started (b)(6) 2017. (b)(6) 2018, i bought medline 50ft oxygen tubing at a local medical supply store. As soon as i connected it to the concentrator, patient shouted that oxygen was coming through tubing very forcefully (no change made in flow rate). Patient seemed more alert and less unsteady on feet. Dme company agreed to provide brand name 50-foot tubing. No problem was perceived with nasal cannula, so patient continued to use sunset brand res3007 nasal cannula. Over time, patient continued to deteriorate: increased frequency of falls, dizzy even when seated, increasing episodes of resting hr smaller than 100 where o2 saturation dropped greater than 80 in spite of proper oxygen use and breathing technique. Called 911 x 1, took patient to er x 1. Patient became so feeble that breathing was the only activity she could tolerate and had to make effort to breathe in spite of proper use of oxygen equipment. Breathing became such an effort that portable oxygen device could not detect shallow breathing and would alarm as if patient was not breathing. Asked (b)(6) pulmonologist dr. (b)(6) and cardiologist dr. (b)(6) why patient kept having sustained episodes of resting hr less than 100. They had no answers or suggestions. (b)(6) 2018 clinic visit md insisted patient use their tank oxygen and brand name 7-foot tubing due to dangerous low o2 sat using simplygo mini with sunset nasal cannula. As soon as tank and brand name tubing were connected, o2 sat smaller than 94%. Had oxygen concentrator and simplygo mini tested to verify they were working properly per md order. Replaced simplygo mini with simplygo (capable of continuous oxygen), no improvement in o2 sat at home or when using simplygo on continuous oxygen (still using sunset nasal cannula). (b)(6) 2018, took patient to (b)(6). Medical staff documented o2 sat remained between 77-84 in spite of proper posture and breathing technique, until sunset res3007 7-foot tubing was replaced with brand name tubing. When we got home from clinic, i compared sunset and brand name tubing: sunset tubing has inside measurement that measures wider than brand name tubing, altering the oxygen concentration received by patient (explains why brand name tubing provides a more forceful flow of oxygen - as patient remarked on (b)(6) 2018). (b)(6) 2018, (b)(6) clinic faxed letter to dme company (b)(4), ordering them to provide patient with brand name tubing due to problem with sunset brand. I spoke by phone with (b)(4), respiratory therapist, (b)(4). Was told (b)(4) will no longer use sunset brand tubing for any of their patients. "when i discovered problem with sunset tubing (b)(6) 2018, i called the order line for (b)(4) (not the local office) and was told they only purchase sunset tubing, so that is what they will ship. The local office took it upon themselves to provide us with brand name tubing and as of (b)(6) 2018, that included brand name nasal cannulas.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5078464
MDR Report Key7697774
Date Received2018-07-17
Date of Report2018-07-13
Date of Event2018-06-08
Date Added to Maude2018-07-18
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameSUNSET BRAND OXYGEN TUBING 7 FT WITH NASAL CANNULA
Generic NameCANNULA NASAL, OXYGEN
Product CodeCAT
Date Received2018-07-17
Model NumberRES3007
Catalog NumberRES3007
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSUNSET HEALTHCARE SOLUTIONS

Device Sequence Number: 2

Brand NameSUNSET OXYGEN TUBING (50FT)
Generic NameTUBING, PRESSURE, ACCESSORIES
Product CodeBYX
Date Received2018-07-17
Model NumberRES3050
Catalog NumberRES3050
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerSUNSET HEALTHCARE SOLUTIONS


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2018-07-17

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