MAUDE Adverse Event Report: ST PAUL CADD; CASSETTE RESERVIORS.

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 malfunctioned.The report indicated leaking was occurring on the top where the little blue thing piece is.No patient adverse events reported.

Manufacturer Narrative

Other, other text: additional information: h6, h10: device evaluation: four smiths medical cadd cassette reservoir were returned for analysis in a used condition.Visual inspection was performed and indicated that the sample using did not present any damage, scuffs, pinch marks, cracks, crazing, cuts, etc.That could cause the failure mode reported.During functional testing, leak testing on the unit received was performed and the sample was rejected by leak test equipment.Leak was noted in the join with the tube of the bag; therefore, it confirmed the failure mode reported.Based on the evidence, the complaint was confirmed, and the problem source of the reported event was noted to be manufacturing.

Event Description

2/4 reference cc-0100660 for all attachments and related complaints) per email: problem with the 100cc cassettes.They are leaking on the top where the little blue thing is.

Manufacturer Narrative

, corrected data: updated g 4 on correct aware dated as year should be 2021.

• Brand Name: CADD
• Type of Device: CASSETTE RESERVIORS.
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11399534
• MDR Text Key: 234282199
• Report Number: 3012307300-2021-01663
• 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,Followup
• Report Date: 05/14/2021

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: 4046848
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/10/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1