MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION HOME PD SYSTEM KAGUYA SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number T5C4600

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 02/20/2021

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported there was a crack on the patient line of a kaguya set which resulted in leak.This occurred during dwell two of three of peritoneal dialysis therapy.The leak was further described as ¿solution seems to leaked a little¿.The patient was advised to abort therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: HOME PD SYSTEM KAGUYA SET
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; singapore 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 11517164
• MDR Text Key: 245857277
• Report Number: 1416980-2021-01424
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: T5C4600
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2021
• 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