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

Catalog Number L5C4531

Device Problem Air/Gas in Device (4062)

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

Event Type  malfunction  

Event Description

It was reported that there was air in the patient line of three (3) homechoice cassettes without an alarm.This occurred during dwell phase of peritoneal dialysis therapy.The home patient (hp) was connected at the time of the event.There was nothing unusual found during troubleshooting that would cause or contribute to the event.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The events occurred on an unspecified date, reported as "over the last couple weeks." should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

B5: the event was further described as the patient saw ¿air bubbles in the patient line¿.H10: the actual devices were not available; however, a companion sample was received for evaluation.The visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.Additionally, the set was machine tested (simulated use) with no issues noted; there was no evidence of bubbles through the set during testing.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• 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 - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16992533
• MDR Text Key: 315879190
• Report Number: 1416980-2023-02523
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00085412090078
• UDI-Public: (01)00085412090078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102936
• 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: 06/28/2023

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: L5C4531
• Device Lot Number: H23B17094
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 06/26/2023
• Supplement Dates FDA Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/17/2023
• 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