MAUDE Adverse Event Report: UNITED THERAPEUTICS/DEKA RESEARCH & DEVELOPMENT CORP. REMUNITY CASSETTE; SET, I.V. FLUID TRANSFER

Device Problems Break (1069); Leak/Splash (1354); Device Difficult to Setup or Prepare (1487)

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

Event Type  malfunction  

Event Description

Spontaneous report from patient's mother who reported that the patient is out of remodulin because yesterday she had issues when making the new cassette and she ended up wasting medication for 2 cassettes.She reported that when she made the first cassette, the tip of the needle broke inside and the second cassette was leaking.Both cassettes were discarded.She did not provide any lot numbers for the affected cassettes.The third cassette created yesterday was fine and that is what the patient is currently using.Patient is on subcutaneous remodulin therapy using remunity pumps.Patient's mother did not report that patient experienced any changes in breathing or side effects.No other information provided.Subcutaneous self-fill remunity pt.Pt actively on uptravi and tadalafil.Did the reported product fault occur while in use with the patient? yes.Did the product issue cause or contribute to patient or clinical injury? no.If yes, was any medical intervention provided? please explain.N/a.Is the cassette available to be returned for investigation? no.What is the outcome of the event? resolved.Describe in detail any, and all damage to the cassette.Has this incident happened within the past 6 months? (offer nursing evaluation).Reported to cvs/caremark by: patient/caregiver.Reference reports: mw5119299, mw5119300.

• Brand Name: REMUNITY CASSETTE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): UNITED THERAPEUTICS/DEKA RESEARCH & DEVELOPMENT CORP.; 340 commercial st.; manchester NH 03101
• MDR Report Key: 17309327
• MDR Text Key: 319050844
• Report Number: MW5119301
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• 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: 07/06/2023

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: 07/11/2023
• Patient Sequence Number: 1
• Treatment: REMODULIN.; REMUNITY PUMP.; TADALAFIL.; UPTRAVI.
• Patient Sex: Male