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

Model Number CADD CASSETTE RESERVOIRS - FLOW STOP

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Diarrhea (1811); Headache (1880)

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

No serial number was provided as the person reporting event believes may or may not be these numbers.(b)(6).

Event Description

Information received a smiths medical cadd® medication cassette reservoirs flow stop had under infused.The reported medication that is to infuse over twenty-four hours, has a rate of 3.5 milliliters per hour, with sixteen milliliters left in usually the reservoir.Thirty milliliters was left remaining in cassette reservoir.A female consumer reported this to dr.(b)(6), on (b)(6), 2019.Symptoms of reported side effects of under dosing and concern for medication left in cassette, was headache and diarrhea.No patient permanent or life threatening injury reported.

Manufacturer Narrative

H2: correction: see b3.H3: one cadd cassette reservoirs from p/n 21-7302-24 l/n 3716383 was received in used conditions without its original packaging inside in a plastic bag.The sample was visually inspected, at a distance of 12" to 24" and normal conditions of illumination.The cassette was in good condition with a tube not manufactured by smiths medical of tijuana.The sample was connected to the cadd legacy plus and a balance mettler to look for unusual function.The sample passed accuracy tests successfully.Relevant documents were reviewed and deemed adequate and correct with respect to testing and inspection activities.The reported under infusion issue was unable to be confirmed.There was no fault found with the returned cassette.

• Brand Name: CADD® MEDICATION CASSETTE RESERVOIRS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9325445
• MDR Text Key: 175931854
• Report Number: 3012307300-2019-06476
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586027233
• UDI-Public: 30610586027233
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/24/2024
• Device Model Number: CADD CASSETTE RESERVOIRS - FLOW STOP
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 3776385
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR