MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD LEGACY PUMP; PUMP, INFUSION

Model Number 6400

Device Problems Device Alarm System (1012); Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Date 11/26/2019

Event Type  malfunction  

Event Description

Information was received indicating that during use of this smiths medical cadd legacy pump, the pump was not infusing medication and the pump did not displayed warning beep or error code.It was reported that patient was instructed to go to hospital because the patient was without medication (remodulin) for 2 hours.Reported that the patient was admitted to the emergence room for a day until the new pump arrived.No patient consequences were reported.

• Brand Name: CADD LEGACY PUMP
• Type of Device: PUMP, INFUSION
• 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 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 9537100
• MDR Text Key: 173385475
• Report Number: 3012307300-2019-07083
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586019548
• UDI-Public: 10610586019548
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6400
• Device Catalogue Number: 21-6400-51
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2000
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 39 YR
• Patient Weight: 80