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 08/02/2019

Event Type  malfunction  

Manufacturer Narrative

No serial number was provided as the person reporting event believes may or may not be these numbers: (b)(4).

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.

• 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
• Manufacturer (Section G): SMITHS MEDICAL ASD,INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 lane n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 9098613
• MDR Text Key: 159620917
• Report Number: 3012307300-2019-04891
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586027233
• UDI-Public: 30610586027233
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/19/2019

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
• Device Operator: Lay User/Patient
• Device Model Number: CADD CASSETTE RESERVOIRS - FLOW STOP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR