MAUDE Adverse Event Report: NULL CADD-LEGACY 1 AMBULATORY INFUSION PUMP; PUMP, INFUSION

Model Number 6400

Device Problem False Alarm (1013)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation- the returned device was given functional testing.After power-up, the device gave a double beep alarm.An issue with the downstream occlusion sensor was determined the cause of the problem.The cause of the component issue was not established.

Event Description

It was reported that the device gave a "double beep" with a "no cassette attached" alarm.No known adverse effects to patient.

• Brand Name: CADD-LEGACY 1 AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section G): NULL
• Manufacturer Contact: david halverson ; 6000 nathan lane north; ste 100; minneapolis, MN 55442
• MDR Report Key: 8207124
• MDR Text Key: 131744374
• Report Number: 3012307300-2018-05354
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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