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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MICRO-VOLUME EXTENSION SET; FILTER, INFUSION LINE
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BAXTER HEALTHCARE CORPORATION MICRO-VOLUME EXTENSION SET; FILTER, INFUSION LINE Back to Search Results
Catalog Number 2N3350
Device Problem No Flow (2991)
Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)
Event Date 02/05/2021
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during patient infusion of epinephrine with a micro volume extension set, a ¿clogged medication line¿ was observed.It was reported the patient ¿had to be treated for hypertension¿.It was reported a tubing change was performed.It was also reported the patient was given albumin bolus for hypotension.At the time of this report, the patient outcome was not reported.No additional information is available.
 
Manufacturer Narrative
The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
MICRO-VOLUME EXTENSION SET
Type of Device
FILTER, INFUSION LINE
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11453485
MDR Text Key238860127
Report Number1416980-2021-01186
Device Sequence Number1
Product Code FPB
Combination Product (y/n)Y
PMA/PMN Number
K113227
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2N3350
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received04/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ONE-LINK LUER DEVICE; ONE-LINK LUER DEVICE
Patient Outcome(s) Required Intervention;
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