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

Device Problems Defective Component (2292); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Spontaneous.Patient reports that her current pump all of a sudden started alarming with no code so she moved her cassette to her back up pump and same thing happened.Alarm with no code.Advised patient to use new cassette to see if same issue occurs.Patient used new cassette with no issues.No interruption in therapy.Confirmed dose 83 nkm, 32 ml/24hr pump rate.Using 3 ml remodulin 10 mg/ml every 48 hours.Serial number: (b)(6) / maintenance due date: 8/2023.Serial number:(b)(6) / maintenance due date: 10/2023.Resolved.No additional info, details, or dates available.Return tracking information is not available.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unknown.Position of the pump when alarm occurred is unknown; 430685 / maintenance due date: 08/2023, serial number: (b)(6)/ maintenance due date: 10/2023.Did the reported product fault occur while in use with the pt? yes; did the product issue cause or contribute to pt or clinical injury? no; is the actual product available for investigation? unk; did we replace the product? no; did the pt have a backup product they were able to switch to? yes; was the pt able to successfully continue their therapy? yes.Reported to cvs/caremark by pt/caregiver.Reference report: mw5116912.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16795306
• MDR Text Key: 313936869
• Report Number: MW5116911
• 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: 04/08/2023

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
• Device Expiration Date: 08/01/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2023
• Patient Sequence Number: 1
• Treatment: REMODULIN
• Patient Sex: Female