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

Model Number 21-7363-24

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 11/17/2020

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical pump was leaking at the filter after priming the disposable.There were no reported adverse events.

Event Description

Investigation completed.

Manufacturer Narrative

Investigation completed on a smiths medical ambulatory infusion pumps|cadd administration sets - flow stop.Visually inspected device and not able to confirm defect.Leak test completed using hydrostatic vessel and leak was observed.The complaint was observed.Engineering manufacturing reviewed and no discrepancies as device passed 100% prior to release.Theory of cause to believe after leaving manufacturing.

Event Description

Investigation completed and summary in h 10.

Manufacturer Narrative

Investigation completed on a smiths medical ambulatory infusion pumps|cadd administration sets - flow stop.Visually inspected device and not able to confirm defect.Leak test completed using hydrostatic vessel and leak was observed.The complaint was observed.Engineering manufacturing reviewed and no discrepancies as device passed 100% prior to release.Theory of cause to believe after leaving manufacturing.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 11007796
• MDR Text Key: 221456985
• Report Number: 3012307300-2020-12369
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517161960
• UDI-Public: 15019517161960
• Combination Product (y/n): N
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 21-7363-24
• Device Lot Number: 4019452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 12 MO
• Patient Weight: 7