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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC CADD EXTENSON SETS SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD,INC CADD EXTENSON SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 0.2 MCRN FILTR
Device Problem Fluid Leak (1250)
Patient Problems Chest Pain (1776); Pulmonary Dysfunction (2019); Swelling (2091); High Pulmonary Arterial Wedge Pressure (2480)
Event Date 01/10/2019
Event Type  malfunction  
Event Description
Information received a smiths medical cadd extension set were leaking medication out of the filter. Medication was used for pulmonary artery hypertension and noted enough medication had leaked causing patient to have a exacerbation of symptoms related to disease and was described as vital. When symptoms of pulmonary arterial hypertension were noted to be exacerbated, treatment was restarted. Serial lot numbers given to related complaint. (b)(4).
 
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Brand NameCADD EXTENSON SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD,INC
6000 nathan lane
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD,INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
dave halverson
6000 lane n
minneapolis, MN 55442
7633833310
MDR Report Key9281633
MDR Text Key165243680
Report Number3012307300-2019-05857
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K974013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,health p
Reporter Occupation
Remedial Action Modification/Adjustment
Type of Report Initial,Followup
Report Date 06/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number0.2 MCRN FILTR
Device Catalogue Number21-7106-24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/05/2019 Patient Sequence Number: 1
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