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

Catalog Number 21-7002-24

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 cadd cassette reservoirs, 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 is1.6 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 cassette reservoirs - non flow stop 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 damaged could be detected on the unit.The sample was connected to the cadd legacy plus to look for unusual function.The sample was fully priming and connected without difficult, the pump was set running and the alarm was not activated.The accuracy test was successfully passed.A review of the manufacturing process for p/n 21-7302-24 l/n 3859512 was conducted by quality intern on 06-aug-19 in order to verify that there are no situations or practices that could create the event as described in "complaint description" section.The cassette bonding operation in the cassette line was reviewed; no discrepancies were found.The bag loading operation in the cassette line was review; no discrepancies were found.Root cause cannot be determined since the complaint was not confirmed due to the fact the accuracy test was successfully passed.No corrective actions are required since the complaint was not confirmed.

• Brand Name: CADD CASSETTE RESERVOIR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8318432
• MDR Text Key: 135514132
• Report Number: 3012307300-2019-00451
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 21-7002-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Date Manufacturer Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1