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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. CADD SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7346-24
Device Problems Insufficient Flow or Under Infusion (2182); Failure to Infuse (2340)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2022
Event Type  malfunction  
Event Description
It was reported that the patient connected to cadd pump via picc line. Patient returned the second day to report full bag of medication had not infused. Cadd pump indicated 106ml to be infused for another 5 hours according to settings, however bag remained full. Cadd pump switched and same bag and tubing connected. Patient sent home and instructed to return next morning. Patient returned with bag still full of medication. Cadd pump indicated 108mls more to be infused for another 5 hours. A new epoch(etoposide, doxorubicin, vincristine) bag and tubing attached and same cadd pump used. Patient sent home and instructed to return to center at 1600c-hrs. Patient returned and 120mls of drug infused. No patient injury was reported.
 
Manufacturer Narrative
Device evaluation: no product was returned. We are unable to confirm the reported complaint. If the product is returned, smiths medical will reopen this complaint for further investigation.
 
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Brand NameCADD
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
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key14362436
MDR Text Key291629914
Report Number3012307300-2022-08555
Device Sequence Number1
Product Code FPA
UDI-Device Identifier15019517161953
UDI-Public15019517161953
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K031361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7346-24
Device Lot Number4235006
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/17/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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