MAUDE Adverse Event Report: ST PAUL CADD LEGACY PLUS PUMP; PUMP, INFUSION

Model Number 6500

Device Problems Device Alarm System (1012); Material Fragmentation (1261)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical cadd legacy plus pump exhibited cassette not attached error.No adverse effects were reported.

Manufacturer Narrative

Other, other text: customer reported that the cassette was not attached.Tamper seals were intact ,the cosmetic was in good condition.The reported cassette not attached,problem was not duplicated.Ran the pump in user mode.The problem was caused by the medication reservoir is defective.Unable to determine who caused the problem.The pump will undergo standard pm.

Event Description

It was reported that the cassette was not attached.No patient injury was reported.

Event Description

It was reported that the cassette was not attached.No patient injury was reported.

Manufacturer Narrative

Customer reported that the cassette was not attached.Tamper seals were intact ,the cosmetic was in good condition.The reported cassette not attached,problem was not duplicated.Ran the pump in user mode.The problem was caused by the medication reservoir is defective.Unable to determine who caused the problem.The pump will undergo standard pm.

• Brand Name: CADD LEGACY PLUS PUMP
• Type of Device: PUMP, INFUSION
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11862288
• MDR Text Key: 251903238
• Report Number: 3012307300-2021-04769
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586019647
• UDI-Public: 10610586019647
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 6500
• Device Catalogue Number: 21-6500-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1