MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number ASKU

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Protective Measures Problem (3015)

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

Event Date 03/16/2023

Event Type  malfunction  

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, dominican republic.An alarm indicative of a potential malfunction of the disposable cassette was reported.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.However, a hole in the patient line which resulted in leak, which is known to cause this alarm.The cause of the leak could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a homechoice device alarmed system error 2240 (air in line/set).The patient was connected at the time of the alarm.This occurred during drain two of five of peritoneal dialysis (pd) therapy.During the troubleshooting, it was reported that there was a hole in the patient line which resulted in a leak that led to this alarm.Renal therapy services (rts) assisted the patient with clearing the alarm and advised to contact their nurse regarding the issue.Proper procedures per the user manual were reviewed with the patient.There was no patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: NI
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; see h10; see h10; see h10
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16709882
• MDR Text Key: 313012699
• Report Number: 1416980-2023-01666
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• 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: 03/16/2023
• 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