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

Other, other text: h6: event problem and evaluation codes: updated after device evaluation h10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Samples received: the samples consist of twenty six (15) cassette units from p/n 21-7302-24 l/n 4037756; twenty one (21) of the samples were returned with its original closed package and five (5) of the units were returned decontaminated without their original package.Visual inspection results: the sample unit do not present any damage, scuffs, pinch marks, cracks, crazing, cuts, etc.Could cause the failure mode reported functional testing: leak testing on the units that were received unopened (21 units) was performed according to the procedure pm-1011 ?cassette leak testing, install ffp clip and luer capping? rev 121 section 1 ?leak testing procedure? using the equipment uson leak tester lt-2-2-111 (calibration id: (b)(4), calibration due date: (b)(6) 2022) to detect leaks in the product.Results: the sample unit pass the leak test.Functional testing: the twenty-six sample units were fill whit colored water using syringe in order to detect any leakage.Results: the twenty-six sample units did not present any leaks.Therefore complaint is not confirmed.The cause of the reported problem could not be determined.

• 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: 12012694
• MDR Text Key: 256709042
• Report Number: 3012307300-2021-06141
• 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
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/16/2021
• Supplement Dates Manufacturer Received: 11/17/2021
• Supplement Dates FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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