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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. VERSASAFE SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION 303, INC. VERSASAFE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 10807851
Device Problem Particulates (1451)
Patient Problems Atrial Fibrillation (1729); Bacterial Infection (1735); High Blood Pressure/ Hypertension (1908); Rash (2033); Swelling (2091); Dysphasia (2195)
Event Date 08/05/2019
Event Type  malfunction  
Event Description
Elderly male with paroxysmal atrial fibrillation, hypertension, and chronic kidney disease who was admitted for circulatory shock and found to have (b)(6). Pt reported sudden onset of facial swelling and he also had rashes on bilateral le, erythematous spots which are not raised and not itchy. His left arm was swollen at the iv site (at the site of his amiodarone infusion) and amiodarone tubing filter is noted with significant brown sediment. Pt has tolerated amiodrone previously prior to switching to sotalol after 2 months of therapy. Chart notes without edits: "pt noted increased lip swelling and spotty macular rash which slowly improved throughout the day and is nearly resolved the next morning. No other swelling in the face or tongue. No difficulty with managing secretions or difficulty speaking. The only two new medications he took the day before were imodium and melatonin, neither of which are thought to be high risk for hypersensitivity. Amio filter did have some particulate matter in it. Worth mentioning that he was on steroids until 2 days before, which may have been masking other medication side-effects".
 
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Brand NameVERSASAFE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd.
san diego CA 92121
MDR Report Key9140005
MDR Text Key160777873
Report Number9140005
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2019
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number10807851
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/27/2019
Event Location Hospital
Date Report to Manufacturer10/01/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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