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

Device Problems Material Fragmentation (1261); Audible Prompt/Feedback Problem (4020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2020

Event Type  malfunction  

Manufacturer Narrative

The lot number was not provided.

Event Description

Information was received indicating that the cadd cassette might have contributed to displayed an alarm displayed by the pump that there was no disposable attached.It was also reported that upon inspection the patient noted a green piece of cassette is broken.The patient re-mixed the medication using a new cassette.The infusion was life sustaining and the patient was able to continue the therapy.There was no injury to the patient.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section G): NULL
• MDR Report Key: 11316279
• MDR Text Key: 231567819
• Report Number: 3012307300-2021-01183
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2021
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR