MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION AMIA AUTOMATED PD CYCLER SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 5C5479

Device Problem Failure to Disconnect (2541)

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

Event Type  malfunction  

Event Description

It was reported that the patient line of the homechoice cassette was unable to be disconnected from the transfer set.The event was further described as ¿were untwisting at the dark blue tip instead of at the valve¿.This was observed during use of the devices for peritoneal dialysis therapy.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

Additional information was added to d1, d4 (catalogue #), d9, g1 (device manufacturer name and address), g4, h3, h6, and h10.H10: two (2) actual devices were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The patient connectors were connected and disconnected from the female connectors of the transfet set by hand with no issues observed.The reported connection issue was not verified.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information added to b3/d10: the event occurred on an unspecified date in january 2024, reported as "over the past week." should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: AMIA AUTOMATED PD CYCLER SET
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; see h10; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18699957
• MDR Text Key: 335818290
• Report Number: 1416980-2024-00539
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5C5479
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: TRANSFER SET.