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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. CADD® ADMINISTRATION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7036-01
Device Problems Leak/Splash (1354); Insufficient Flow or Under Infusion (2182)
Patient Problems Complaint, Ill-Defined (2331); Underdose (2542)
Event Date 06/30/2016
Event Type  Injury  
Manufacturer Narrative
Voluntary medwatch form #: mw5066840. The reporter noted the incident occurred in (b)(6) 2016. Customer has not returned the device to the manufacturer for device evaluation. If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
 
Event Description
It was reported that a cadd® administration set had an issue of serious underinfusion and leaking. The underinfusion was between 15% and 56%, and the patient was compromised and needed additional care. The patient required higher levels of monitoring. It was unclear what the impact to the patient was. See mfr: 3012307300-2017-00467, 3012307300-2017-00468, 3012307300-2017-00469, 3012307300-2017-00470, 3012307300-2017-00471, 3012307300-2017-00472, 3012307300-2017-00473, 3012307300-2017-00474, 3012307300-2017-00475, 3012307300-2017-00476, and 3012307300-2017-00477.
 
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Brand NameCADD® ADMINISTRATION SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana, b.c. 22425
MX 22425
Manufacturer Contact
lisa perz
6000 nathan lane north
minneapolis, MN 55442
7633833074
MDR Report Key6339102
MDR Text Key67722184
Report Number3012307300-2017-00477
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K933390
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number21-7036-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 02/17/2017 Patient Sequence Number: 1
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