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

Device Problem Device Alarm System (1012)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information was received indicating that a pump alarmed indicating that there was no cassette.It was noted that the smiths medical cadd cassette was fitted by the service on one of their pumps but delivered another alarm.No adverse effects were reported.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section G): NULL
• MDR Report Key: 11086960
• MDR Text Key: 224045499
• Report Number: 3012307300-2020-12795
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2020

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: 11/30/2020
• Initial Date FDA Received: 12/29/2020
• 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