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

Model Number 6500

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 02/13/2024

Event Type  malfunction  

Event Description

It was reported that pump was finished infusion five hours early, in addition to the disposable leaking.The pump was used to prime the extension tubing.Continuous infusion rate: 2.2ml/hr.Reservoir volume: 100ml.Given: total volume.Air detector was off.Upstream sensor was off.Drug: 5fu.Length of infusion: 46.Lock level: 2.There was a cstd used to fill cassette.

Manufacturer Narrative

Device not received by manufacturer.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

No product was returned.The investigation determined the most probable cause to be unintentional use.However, this cannot be confirmed as no product was returned for investigation.If the product is returned this complaint will be reopened for further investigation.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• Brand Name: CADD LEGACY PLUS PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18908307
• MDR Text Key: 337738099
• Report Number: 3012307300-2024-01371
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6500
• Device Catalogue Number: 21-6500-51
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 5FU; CADD CASSETTE; CADD TUBING; CSTD