MAUDE Adverse Event Report: ST PAUL CADD; DISPOSIBLE

Model Number	21-7355-24
Medical Device Problem Codes	Material Separation (1562); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a product disposable related to cadd pump caused under delivery.The disposable caused malfunction, which interrupted the tpn therapy and caused under delivery of the tpn.Tpn is given for parenteral nutrition for the immune compromised patient.Customer states three times the filter fell off/came apart.Air was in line.Wasted tpn infusion drug.Occurred immediately on use and during removal or at the end of therapy.
Additional Manufacturer Narrative
Device evaluation: one smiths medical cadd administration set was returned for analysis in a used condition.The sample was visually inspected under normal conditions of illumination and it could be observed that the filter was broken from its output to tubing line.Based on the evidence, the complaint was confirmed, and the problem source of the reported event is unknown.

• Brand Name: CADD
• Common Device Name: DISPOSIBLE
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10338954
• Report Number: 3012307300-2020-07656
• Device Sequence Number: 14389974
• Product Code: FPA
• UDI-Device Identifier: 10610586027376
• UDI-Public: 10610586027376
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K031361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2020

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?: No
• Operator of Device: No Information
• Device Expiration Date: 01/09/2025
• Device Model Number: 21-7355-24
• Device Catalogue Number: 21-7355-24
• Device Lot Number: 3926583
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1