MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD-MS 3 AMBULATORY INFUSION PUMP; PUMP, INFUSION

Model Number 7400

Device Problem Loss of Data (2903)

Patient Problem Unspecified Infection (1930)

Event Type  malfunction  

Event Description

Information was received indicating that a patient did not receive their programmed infusion using the smiths cadd-ms3 ambulatory infusion pump because the pump lost its programmed settings.It was also reported that the patient had pain due to a sire infection.The patient does not allege that the infection was cause by the pump's malfunction.The patient switched to a backup pump to receive their infusion.

Manufacturer Narrative

Returned device was received in good physical condition.No evidence of reported problem in event log was found.During the evaluation of the device, analysts were unable to replicated the customer's reported issues.The device ran for an extended period of time without having any issues occurring.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: CADD-MS 3 AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9965386
• MDR Text Key: 187861489
• Report Number: 3012307300-2020-03031
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586029554
• UDI-Public: 10610586029554
• Combination Product (y/n): N
• PMA/PMN Number: K051568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7400
• Device Catalogue Number: 21-7411-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 93