MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number R5C4479

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 09/06/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter postal code: (b)(6).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; 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 that a homechoice device experienced a system error 2367 (air in line/set) alarm.The patient was connected at the time of the alarm.This occurred during initial drain of peritoneal dialysis therapy.During troubleshooting, it was reported that there was a hole in the homechoice cassette which resulted in a leak that led to this alarm.The leak was further described as ¿liquid coming out the door¿ and ¿fluid all over the floor." renal therapy services (rts) assisted the patient in removing the cassette and advised to start over with new supplies.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: HOMECHOICE AUTOMATED PD SET WITH CASSETTE
• 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 60073 ; 2242702068
• MDR Report Key: 17855242
• MDR Text Key: 324737544
• Report Number: 1416980-2023-04966
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00085412030531
• UDI-Public: (01)00085412030531
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K102936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: R5C4479
• Device Lot Number: S23E04019
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2023
• Date Device Manufactured: 05/04/2023
• 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 CLARIA DEVICE; UNSPECIFIED SOLUTION