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

Catalog Number BBC8314P

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

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

Event Date 06/11/2022

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a crack was noted in the cassette component of a homechoice automated pd set which resulted in a leak.This occurred while priming the device for peritoneal dialysis (pd) therapy on a homechoice (hc) machine.The event was further described as ¿liquid is coming out through the door¿ of the hc.As a result, the priming of the lines was stopped.Renal therapy services assisted the patient and the machine was turned off and turned back on inorder to remove the cassette from the machine.The cassette was checked and a crack was noted with liquid coming out of the crack.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added to d9, h3, h6 (add codes) and h10.H10: one (1) actual sample was received for evaluation.A visual inspection with the naked eye noted a crack on the cassette.Additionally, twelve (12) retention samples were visually inspected with no issues noted.The reported condition was verified on the actual sample; however, not verified on the retention samples.The cause of the crack could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the actual device was not available; however, five (5) photographs of the sample were provided for evaluation.The returned photographs were reviewed, and it was noted that the cassette was damaged.The reported condition was verified.The cause of the condition could not be determined.A nonconformance has been opened to address this issue.A batch review was conducted and there were no deviations found related to this reported 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 - ATLACOMULCO; av. ing. salvador sanchez; colin no. 9; atlacomulco CP 50 450; MX CP 50450
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 14932734
• MDR Text Key: 295993636
• Report Number: 1416980-2022-03483
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00854126102380
• UDI-Public: (01)00854126102380
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2022

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: BBC8314P
• Device Lot Number: 29DBHC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/11/2022
• Initial Date FDA Received: 07/06/2022
• Supplement Dates Manufacturer Received: 08/05/2022; 08/24/2022
• Supplement Dates FDA Received: 08/10/2022; 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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 CYCLER; UNSPECIFIED PD SOLUTION