MAUDE Adverse Event Report: NULL CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR,

Device Problem No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Information was received indicating that an anonymous cadd-solis ambulatory infusion system post market clinical follow up survey reported non-delivery of medication.It was reported that the pump counted the delivery, but the bag "remained intact." per survey the solution was found in the recall of the tubing.No further information: item number, serial number, etc., will be available.This survey was distributed to eight different countries within the eu, us, and (b)(6), therefore the country of origin is also unknown.

• Brand Name: CADD ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR,
• Manufacturer (Section G): NULL
• MDR Report Key: 13079167
• MDR Text Key: 282729531
• Report Number: 3012307300-2021-13236
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2021

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?: Yes
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1