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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
Device Problem Obstruction of Flow (2423)
Patient Problems Death (1802); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Information was received indicating that a patient was hospitalized twice for a line blockage. The patient uses a smiths cadd legacy pump to provide therapy but is unknown if the device caused the reported event. It was also reported that the patient developed a low blood pressure while in the hospital.
 
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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 MEDICAL ASD, INC
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
dave halverson
6000 nathan lane north
minneaplois, MN 55442
7633833310
MDR Report Key8382885
MDR Text Key137574061
Report Number3012307300-2019-01082
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2019
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: 03/01/2019 Patient Sequence Number: 1
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