MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; INTRAVASCULAR ADMINISTRATION SET

Device Problems Insufficient Flow or Under Infusion (2182); Inaccurate Delivery (2339)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/1901

Event Type  malfunction  

Event Description

Information was received regarding a cadd solis hpca pump.It was reported that the cassette hooking mechanism resisted abnormally, causing issues with cassettes not properly attached (causing treatment to stop flowing).There was no patient, or clinician injury associated with these occurrences.Pain could not be relived an patient did not receive treatment, but no intervention required.No further details provided at this time.

• Brand Name: CADD
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 12544998
• MDR Text Key: 274562489
• Report Number: 3012307300-2021-09645
• 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: foreign,user facility
• Type of Report: Initial
• Report Date: 09/29/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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