MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE MEDICAL ASD, INC.; SET, I.V. FLUID TRANSFER

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Call transferred from dana, spoc.Spoke with patient.Patient stated she continues to have issues with cassettes.She is not home, so she does not have the lot it the last two she had an issue with are in the trash, patient did not quarantine.She says alarms beeps, she takes cassette off, adjust and then it'll work or sometimes she primes 2-3 times and it will then work.She says it's the cassettes and not a training issues.She denied cnss assistance.Reported to (b)(6) by pt/caregiver.Reference report mw5116853.

• Brand Name: CASSETTE MEDICAL ASD, INC.
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16775940
• MDR Text Key: 313933554
• Report Number: MW5116854
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2023
• Patient Sequence Number: 1
• Patient Sex: Female