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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CADD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7106-24
Device Problems Fluid Leak (1250); Material Puncture/Hole (1504); Insufficient Flow or Under Infusion (2182)
Patient Problem Dyspnea (1816)
Event Date 05/09/2019
Event Type  malfunction  
Manufacturer Narrative
Report source: (b)(6). Related to file number: 3012307300-2019-03279.
 
Event Description
Information was received indicating that a smiths medical cadd extension set was leaking at the filter. It was reported that the patient woke up due to their clothes being wet. Subsequently the patient contacted a nurse who, after arriving at the patient's home, noticed the set to be leaking at the filter. It was reported that the nurse then changed the set as well as the cassette, restarted the veletri treatment and that following the change the new set was also found to be leaking. It was reported that the patient showed shortness of breath. No additional adverse patient effects were reported.
 
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Brand NameCADD EXTENSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. .
ave calidad no. 4,
parque industrialinternacional
tijuana, 22425
MX 22425
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key8689319
MDR Text Key147705614
Report Number3012307300-2019-03402
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K974013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7106-24
Device Catalogue Number21-7106-24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/05/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/10/2019
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 Unkown

Patient Treatment Data
Date Received: 06/11/2019 Patient Sequence Number: 1
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