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

Model Number 21-7600-24

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 05/18/2020

Event Type  malfunction  

Event Description

Information was received that during use of this smiths medical cadd cassette reservoirs, the customer noticed medical fluid leaking from where the cassette's connector and extension tube connected.No reported adverse effects or patient injury.

Manufacturer Narrative

Investigation completed on a smiths medical ambulatory infusion pumps|cadd cassette reservoirs - flow stop.Samples returned p/n 21-7600-24 manufactured with the lot 3883724 in not its original packaging.Visual inspections under procedure ?visual inspection? md01-003 rev.102 revealed no discrepancies.When functional testing was down to infuse water the complaint was verified.All manufacturing process was reviewed.Root cause investigation and corrective actions will be follow by capa process, through capa-000713 open on september 22nd 2020.By the date that this investigation report is documented capa-000713 is under investigation phase.The expected due date of this investigation phase is november 23rd.

Event Description

Investigation completed on a smiths medical pumps|cadd cassette reservoirs - flow stop.

• Brand Name: NRFIT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10159521
• MDR Text Key: 195302732
• Report Number: 3012307300-2020-05985
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 10610586044007
• UDI-Public: 10610586044007
• Combination Product (y/n): N
• PMA/PMN Number: K162219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/10/2021
• Device Model Number: 21-7600-24
• Device Catalogue Number: 21-7600-24
• Device Lot Number: 3883724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1