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

Catalog Number ASKU

Device Problems Loose or Intermittent Connection (1371); Air/Gas in Device (4062)

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

Event Date 05/30/2023

Event Type  malfunction  

Event Description

It was reported that there was a loose connection between the patient line of a home choice cassette and a transfer set; there was over 1.5 inches of air in the patient line.This occurred during initial drain of peritoneal dialysis (pd) therapy.Renal therapy services (rts) assisted the patient in ending the therapy session.Rts advised the patient to start over with all new supplies and contact their nurse regarding the event.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.

Manufacturer Narrative

B5: during follow up it was clarified that the connection was not properly tightened prior to therapy which led to the connection issue; there was no damage observed to the patient line connector of the cassette.No other information provided.H10: upon further review of this report, it was determined that the baxter homechoice cassette is no considered a suspect product in this event.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 17192321
• MDR Text Key: 318206205
• Report Number: 1416980-2023-03115
• 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,Followup
• Report Date: 07/26/2023

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 Operator: Lay User/Patient
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/23/2023
• Supplement Dates Manufacturer Received: 06/29/2023
• Supplement Dates FDA Received: 07/27/2023
• 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.; TRANSFER SET.; UNSPECIFIED PD SOLUTION.