MAUDE Adverse Event Report: ST PAUL CADD; INFUSION PUMP

Model Number 21-7302-24

Device Problems Filling Problem (1233); Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Information was received regarding a cadd cassette reservoir.It was reported that once the pouch has been filled with 100ml of solution, one can see the liquid go into the empty space between the pouch and the case.By tilting the pouch, it comes out through the openings in the case.This occurred during the patient's sleep hours.Over the course of the week, the customer found the problem in 6 of the 12 pouches used.There was no patient, or clinician injury associated with this occurrence.

Manufacturer Narrative

D5 is unknown.No information has been provided to date.Device evaluation: samples were returned for investigation.A visual inspection of the sample found no present damage, scuffs, pinch marks, cracks, crazing, cuts, etc.That could cause the reported failure.During functional testing, no leaks were identified.The reported failure was not confirmed.The root cause cannot be established.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

Manufacturer Narrative

D5 is unknown.No information has been provided to date.Device evaluation: samples were returned for investigation.A visual inspection of the sample found no present damage, scuffs, pinch marks, cracks, crazing, cuts, etc.That could cause the reported failure.During functional testing, no leaks were identified.The reported failure was not confirmed.The root cause cannot be established.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: CADD
• Type of Device: INFUSION PUMP
• 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: david halverson ; 6000 nathan lane north; strada rivalta 46; minneapolis, MN 55442
• MDR Report Key: 12012631
• MDR Text Key: 256708922
• Report Number: 3012307300-2021-06139
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4037756
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/09/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1