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

Catalog Number 21-7106-24

Device Problem Infusion or Flow Problem (2964)

Patient Problems Nausea (1970); Skin Discoloration (2074)

Event Date 01/08/2019

Event Type  malfunction  

Event Description

Information was received that during use of this smiths medical extension sets, delivery accuracy problem was noted.It was reported that the flow rate on the pump was 95, 92, and the patient's cassette was empty too quickly.Reported that the patient showed symptom of nauseous and color drained away from face.According to the reports the patient normally changes the pump cassettes if there is 1.6 ml left in it, but it appeared that the cassette was already empty while 6.5ml should have been in it after 20 hours of schedule infusion.Subsequently, the patient changed the cassette immediately.No medical intervention required.No additional adverse effects reported.

Manufacturer Narrative

One cadd extension set was returned for analysis in used condition.The sample was visually inspected, at a distance of 12" to 24" and normal conditions of illumination.No discrepancies were found.The test was performed using hydrostat vessel.There was resistance for the fluid to passed through the assembly, the sample was cut and excess solvent was found inside the male luer.The most probable causes are, the operator applied an excessive amount of solvent in the bonding between the tube and the filter.

• Brand Name: CADD EXTENSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8318002
• MDR Text Key: 135511856
• Report Number: 3012307300-2019-00450
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

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 Expiration Date: 06/04/2018
• Device Catalogue Number: 21-7106-24
• Device Lot Number: 3617431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 02/07/2019
• Supplement Dates Manufacturer Received: 08/16/2019
• Supplement Dates FDA Received: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1