MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-MS 3 AMBULATORY INFUSION PUMP; PUMP, INFUSION

Model Number 7411

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

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

Event Date 01/24/2024

Event Type  malfunction  

Event Description

It was reported that while changing the cartridge, remodulin leaked into the pump and the pushrod was not going up.Per the reporter, there were no adverse patient effects.

Manufacturer Narrative

H3: device not received by manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.

Manufacturer Narrative

No product was returned.The investigation determined the most probable cause to be the device being contaminated by remodulin when the cartridge was changed and the tubing may not have been sufficiently tightened resulting in the leak; 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-MS 3 AMBULATORY INFUSION 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18772553
• MDR Text Key: 336668608
• Report Number: 3012307300-2024-00974
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K051568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7411
• Device Catalogue Number: 21-7411-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2013
• 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: CADD MEDICATION CASSETTE RESERVOIR; REMODULIN
• Patient Age: 71 YR
• Patient Sex: Female