MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. CADD LEGACY 1; PUMP, INFUSION

Catalog Number 21-6400-07

Device Problem Inaccurate Delivery (2339)

Patient Problems Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported the pump delivers a different amount of drug than programmed and randomly variable from day to day and too large amount to be compatible with the therapy delivered.No patient injury.

Manufacturer Narrative

Other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

Additional information was received that the user experienced some discomfort as a result of using pumps with marked variations in delivery.

Manufacturer Narrative

Other, other text: no product was returned.We are unable to confirm the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.The most probable cause for an inaccurate infusion/delivery is the expulsor; however, this cannot be confirmed as no product was returned for investigation.The service history review identified an indication that the complaint was related to a service of the device outside of the review period.B3, h4: unknown; d4: udi unknown.

• Brand Name: CADD LEGACY 1
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16844724
• MDR Text Key: 314294585
• Report Number: 3012307300-2023-04814
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 21-6400-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female