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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,FRE; HUMIDIFIER,NEBULIZER KIT
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TELEFLEX MEDICAL HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,FRE; HUMIDIFIER,NEBULIZER KIT Back to Search Results
Catalog Number 003-40F
Device Problem No Flow (2991)
Patient Problem No Code Available (3191)
Event Date 05/12/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Customer reported a desaturation of the patient, but didn't report the severity, or any necessary medical interventions.Prior and current patient condition is unknown.Teleflex has requested information as to the condition of the patient.The device involved has not been returned to the manufacturer at the time of this report.The investigation into this complaint is still in progress.
 
Event Description
Customer complaint alleges ""aquapak installed for a patient with 3 liters of o2.There were bubbles in the bottle but no o2 flow." it was reported this caused a desaturation of the patient.No further details were reported.There was report of medical intervention.
 
Manufacturer Narrative
Teleflex has received additional information regarding the event.The customer reports that "the patient didn't received enough oxygen, so oxygen has been connected directly to the nasal cannula and saturation of the patient finally returned to normal, no further consequences.A review of the manufacturing event log shows no issues that may have contributed to any quality issues reported.All process parameters were within specification.In-process qa inspections show one non-conformance that has no impact on the quality issue reported.Non-conforming material was sorted for a defect, re-inspected, and found to be acceptable per internal specification.The customer returned an empty water bottle (lot 533167) and an 040 humidifier adaptor for evaluation.The water bottle showed the adaptor port was punctured and the trigger was removed.Upon visual examination, no occlusions or other defects to the water bottle and the adaptor were observed.The water bottle was filled approximately half full of water, the adaptor was attached to the water bottle, and the bottle/adaptor assembly was attached to a flow meter.Other remarks: air flow was adjusted from 0lpm to 10lpm.There was air flow at the spout of the bottle throughout the test.Based on the investigation performed, the reported complaint of "no oxygen flow" could not be confirmed.There were no issues found with the returned sample.
 
Event Description
Customer complaint alleges ""aquapak installed for a patient with 3 liters of o2.There were bubbles in the bottle but no o2 flow." it was reported this caused a desaturation of the patient.No further details were reported.There was report of medical intervention.
 
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Brand Name
HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,FRE
Type of Device
HUMIDIFIER,NEBULIZER KIT
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
900 west university dr.
arlington heights IL 60004
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6613855
MDR Text Key76720408
Report Number1417411-2017-00027
Device Sequence Number1
Product Code OGG
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number003-40F
Device Lot Number533167
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/18/2017
Initial Date FDA Received06/06/2017
Supplement Dates Manufacturer Received07/07/2017
Supplement Dates FDA Received07/11/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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