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

Catalog Number R5C4479C

Device Problems Crack (1135); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2020

Event Type  malfunction  

Manufacturer Narrative

Devices were received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that at least 24 homechoice cassettes were defective.It was further described as "seal is broken on the sheeting"; plastic sheeting on the cassette looked cracked.The patient stated that the corner of the plastic sheeting was not sealed.This was noticed during set up of peritoneal dialysis therapy.The packaging of the product was not defective and the patient did not use sharp objects to open the packaging or cassettes.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: h3, h6.H10: twenty-three (23) actual samples were received for evaluation.A visual inspection with the naked eye noted the cassette sheeting was detached at the weld in the corner of the cassettes on all 23 samples.The reported condition was verified.The cause of the condition was related to the welding operation during manufacturing.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
• MDR Report Key: 10308314
• MDR Text Key: 199900729
• Report Number: 1416980-2020-04190
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00085412088433
• UDI-Public: (01)00085412088433
• Combination Product (y/n): Y
• PMA/PMN Number: K102936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: R5C4479C
• Device Lot Number: H20D12011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1