MAUDE Adverse Event Report: ST PAUL CADD; CASSETTE

Model Number 21-7302-24

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 02/05/2021

Event Type  malfunction  

Event Description

Information received a smiths medical ambulatory infusion pumps|cadd cassette reservoirs - flow stop are leaking the hospital reported six cassette were leaking and appeared the bags were to small.Bags were reported broken in the cassette, then it runs out into the opening.No patient adverse events were reported.

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 four (4) cassette from p/n 21-7302-24 l/n 4037752; the returned samples were received two in used conditions without its original package and received two with its original closed package.Visual inspection results: the samples do not present any damage, scuffs, pinch marks, cracks, crazing, cuts, etc.Could cause the failure mode reported.Functional testing: after performed the leak testing the samples were fill whit colored water using a syringe in order to detect any leakage.Results: the samples 3 and 4 present leak in the join with the tube of the bag, therefore it is confirmed the failure mode reported.The complaint is confirmed.The cause of the reported problem was traced to the manufacturing process.Per capa-000713 was open on (b)(6) 2020 it was identified the following root causes: 1.Equipment failure: the bag sealer machine id# bfm-2-1-001 was causing the weak seal condition on the joint of the tube with the bag, the generator of the equipment was identified.2.Procedure not followed: the two forms related to the procedures pm-1011 and pm-1026, for to register units with leak were not filling up, even that was identified the equipment malfunction, as well the method to test the units in both process was not followed as is required, forcing the equipment to release parts with potential leak condition.The following corrective action were implemented thru capa-000713, the current status of the capa is in voe (verification of effectiveness) 1.The rf generator of the bag sealer machine id# bfm-2-1-001 was replaced on (b)(6) 2020.2.Update procedure pm-1011 ?cassette leak testing, install ffp clip and luer capping? to adequate better flow in the execution of the manufacturing activities was implemented on (b)(6) 2021.

• Brand Name: CADD
• Type of Device: CASSETTE
• 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; minneapolis, MN 55442
• MDR Report Key: 11398741
• MDR Text Key: 234241264
• Report Number: 3012307300-2021-01651
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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

• Date FDA Received: 03/02/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2021
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1