MAUDE Adverse Event Report: ST PAUL CADD-LEGACY ONE AMBULATORY INFUSION PUMP

Model Number 6400

Device Problems Device Alarm System (1012); Failure to Prime (1492)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2021

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical cadd-legacy one ambulatory infusion pump exhibited an alarm.Per reporter, there was 6 ml (300mg) left of the medication.Per reporter, the user could not get it to work or prime.No adverse patient effects were reported.Per reporter no additional information is available at this time.

Manufacturer Narrative

Additional contact: (b)(6).

• Brand Name: CADD-LEGACY ONE AMBULATORY INFUSION PUMP
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12972230
• MDR Text Key: 282104242
• Report Number: 3012307300-2021-12560
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6400
• Device Catalogue Number: 21-6400-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2004
• 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