MAUDE Adverse Event Report:; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number ASKU

Device Problem Air/Gas in Device (4062)

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

Event Date 01/15/2024

Event Type  malfunction  

Event Description

It was reported that a patient experienced air in the line of a homechoice cassette.This occurred during initial drain of peritoneal dialysis therapy.The patient was not connected at the time of the event.During the troubleshooting, it was reported that the patient line did not fully prime.Renal therapy services (rts) assisted the patient in ending the therapy session.Rts advised the patient to contact their nurse regarding the missed therapy.Proper procedures per the user manual were reviewed with the patient.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

G1 manufacturing facility - this device was manufactured at one of the two following manufacturing sites: baxter healthcare - mountain home 1900 n highway 201 mountain home, ar 72653 united states.Baxter healthcare - dominican republic carretera sanchez km 18.5, parque industrial itabo, piisa haina, san cristobal 91000 dominican republic.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NI
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• MDR Report Key: 18716479
• MDR Text Key: 335833700
• Report Number: 1416980-2024-00589
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HOMECHOICE DEVICE; UNSPECIFIED PD SOLUTION