MAUDE Adverse Event Report: CADD; INTRAVASCULAR ADMINISTRATION SET

Model Number	21-7321-24
Medical Device Problem Code	Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received regarding a cadd administration set.It was reported that the device gave a "no disposable" alarm with 115ml remaining.Pump settings are unavailable.There was no patient, or clinician injury associated with these occurrences.No further details provided at this time.

• Brand Name: CADD
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12493078
• Report Number: 3012307300-2021-09452
• Device Sequence Number: 4030294
• Product Code: FPA
• UDI-Device Identifier: 10610586029639
• UDI-Public: 10610586029639
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2021

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
• Operator of Device: Health Professional
• Device Model Number: 21-7321-24
• Device Catalogue Number: 21-7321-24
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1