MAUDE Adverse Event Report: ST PAUL CADD; CASSETTE RESERVIOIRS

Model Number 21-7302-24

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 02/01/2021

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: the event date was provided as (b)(6) 2021.

• Brand Name: CADD
• Type of Device: CASSETTE RESERVIOIRS
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11398703
• MDR Text Key: 234240123
• Report Number: 3012307300-2021-01655
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

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 Operator: No Information
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4037752
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1