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

Catalog Number	21-7339-24
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that during use of this smiths medical cadd administration set, pump was not infusing through the tubing despite the epi pump appearing to be functioning normally.It was reported that the pump was started as per usual and after about 2 hours the patient became uncomfortable and used her pcea x3, anesthesia resident called for top up.The top up was given and patient was comfortable for about 45 minutes and then used her pcea again.Upon use of the pcea, the epi pump alarmed, low vtbi and the nurse tried to change the bag when she noticed that the bag was still full.According to the report it appeared as through the cartridge attached to the tubing was not functioning properly.Subsequently, the tubing was changed, and the pump and tubing began to function normally.No patient consequences were reported.No adverse effects were reported.
Additional Manufacturer Narrative
Device evaluation: one smiths medical cadd administration set (part number 21-7339-24, lot number unknown) was returned for analysis in used condition in a plastic bag without its original packaging.Visual inspection showed that the pump tube was slightly crooked and no obstructions or excess solvent were detected in any join.Functional testing involved passing distilled water through the sample using an iv bag to gravity prime.The water flowed with no difficulty observed, the test was passed successfully.Accuracy testing was also performed and no discrepancies were detected, the test was passed successfully.A review of manufacturing processes was performed.It was verified that procedures in the assembly process and quality check process were being properly followed.The problem source could not be identified.Based on the investigation, the complaint allegation was not confirmed.

• Brand Name: CADD ADMINISTRATION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9119473
• Report Number: 3012307300-2019-04886
• Device Sequence Number: 1912971
• Product Code: FPA
• UDI-Device Identifier: 10610586027307
• UDI-Public: 10610586027307
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 21-7339-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1