MAUDE Adverse Event Report: UNKNOWN CASSETTE; SET, I.V. FLUID TRANSFER

Device Problem Expiration Date Error (2528)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Spoke with pt's husband.Pt has cassettes, 4 not used and they are passed the use date.Patient is currently in the icu and receiving hospital medication.Had a procedure on father's day, her blood pressure dropped but the hospital stabilized her.Unknown date of admission/length of stay.Her pulmonologist has stated it's hard to say anything at the moment regarding whether or not she would survive.Husband is hopeful and stated he'll call us once he has an update and inform if he needs cassettes sent if there is a discharge plan.No other information known or provided.Sub-q remunity self- fill patient.Patient actively taking ambrisentan.Reported to (b)(6) by: patient/caregiver.Reference reports: #mw5119012, #mw5119013, #mw5119014.

• Brand Name: CASSETTE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17239194
• MDR Text Key: 318358022
• Report Number: MW5119015
• 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: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2023
• Patient Sequence Number: 1
• Treatment: NAME: AMBRISENTAN.STRENGTH: 10MG.; REMUNITY.
• Patient Outcome(s): Hospitalization
• Patient Sex: Female