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

Model Number 21-7345-24

Device Problems Device Alarm System (1012); Pressure Problem (3012)

Patient Problem No Information (3190)

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

The lot number is unknown.

Event Description

Information was received indicated that air is leaking in to the system when the cadd administration sets - flow stop was being used.The pump alarmed several times that there was air in the line.As a result of the issue, the patient was admitted to the hospital in order to complete the therapy.

• Brand Name: CADD
• Type of Device: SET, 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 Key: 11279247
• MDR Text Key: 230274811
• Report Number: 3012307300-2021-00833
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517191714
• UDI-Public: 15019517191714
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 21-7345-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 02/04/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 5 YR
• Patient Weight: 20