MAUDE Adverse Event Report: NULL RESERVOIR, CASSETTE; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Device Alarm System (1012)

Patient Problems Dyspnea (1816); Insufficient Information (4580)

Event Type  malfunction  

Event Description

Information was received indicating both pumps with a cadd cassette reservoir attached exhibited ?no disposable" alarms and the user has been having cassette issues over the last six months.It was reported the patient mixed a new cassette which resolved the issue.Per reporter the end user reported lowering velletri pump rate to 66ml over 24 hours at last consult, but the user immediately had shortness of breath and the doctor directed the patient to go back up to 71ml over 24 hours.

• Brand Name: RESERVOIR, CASSETTE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section G): NULL
• MDR Report Key: 13576488
• MDR Text Key: 286120767
• Report Number: 3012307300-2022-03772
• 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
• Type of Report: Initial
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• 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
• Date Manufacturer Received: 02/03/2022
• 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
• Patient Sex: Female