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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. CADD CASSETTE RESERVOIRS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7302-24
Device Problems Insufficient Flow or Under Infusion (2182); Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2021
Event Type  malfunction  
Event Description
Information was received indicating that during use of this smiths medical cadd cassette reservoirs, the pump exhibited ?high pressure" error alarm. It was reported that the customer changed the cassette out and reconnected the patient and after about 5 minutes, the pump displayed the same error. According to the reported the patient then refused the rest of the treatment which was 70ml. No patient injury reported.
 
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Brand NameCADD CASSETTE RESERVOIRS
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
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key12414123
MDR Text Key269546216
Report Number3012307300-2021-09096
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 distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7302-24
Device Catalogue Number21-7302-24
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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