MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD® CADD® MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP FREE-FLOW PROTECTION; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7302-24

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received indicating that this cassette caused alarms to occur when used with multiple ambulatory infusion pumps.Troubleshooting ruled out the pumps and was unable to resolve the cassette issue.No adverse patient effects were reported.

Manufacturer Narrative

One cadd® cadd® medication cassette reservoir was returned in used condition.The customer's reported problem was "a no disposable, pump won't run alarm went off".The cassette was visually inspected for damage at a distance of 12" to 24" and normal conditions of illumination.No damage was detected.The sample was connected and tested on a pump.The height of the arch of the pump tube was within specification and no alarms were activated during the testing.The manufacturing and quality inspection processes were reviewed and considered adequate and correct.The failure mode could not be duplicated.The root cause of the reported problem is unknown.

• Brand Name: CADD® CADD® MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP FREE-FLOW PROTECTION
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; a d no.4; parque industrial internaciona; tijuana, bc ; MX
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7397004
• MDR Text Key: 104422509
• Report Number: 3012307300-2018-00655
• 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: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/23/2022
• Device Catalogue Number: 21-7302-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1