MAUDE Adverse Event Report: ST PAUL CADD; INTRAVASCULAR ADMINISTRATION SET

Model Number 21-7302-24

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Date 08/17/2021

Event Type  malfunction  

Event Description

Information was received regarding a cadd cassette reservoir.It was reported that the customer has had three patients in the last few weeks that have received their pumps and by the next day it had started beeping and saying ? not detected." infusystem has not been able to help over the phone, so the patients have all returned there.Customer has tried connecting different pumps, and gets the same error message.Customer cannot see any air in the line or figure out what is happening.The only thing the customer has found that works is drawing out the contents from the cartridge, and putting it into a new, unused cartridge.Then it seems to work fine.These have all been 46 hour infusions.There was no patient, or clinician injury associated with these occurrences.No further details provided at this time.

Manufacturer Narrative

Corrected data: b1, corrected data: corrected data: b1 product problem.

• Brand Name: CADD
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12487288
• MDR Text Key: 271871276
• Report Number: 3012307300-2021-09425
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• 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,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4092493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2020
• 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