MAUDE Adverse Event Report: ST PAUL CADD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7034-24

Device Problems Mechanical Problem (1384); Fitting Problem (2183)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/21/2021

Event Type  malfunction  

Event Description

Information was received indicating that while in use, a smiths medical cadd administration set was difficult to fit on the pump, so an occlusion was identified.It was also reported that the set was impossible to unclip from the pump.The reporter also indicated that patient was insufficiently relieved in terms of pain because the pump went into occlusion in the middle of the night and did not notify the home health agency until 6am.Subsequently, a change of pump and set was performed.No adverse effects were reported.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11349846
• MDR Text Key: 232594423
• Report Number: 3012307300-2021-01382
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586020162
• UDI-Public: 10610586020162
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K895046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 21-7034-24
• Device Catalogue Number: 21-7034-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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