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

Catalog Number 5C4469C

Device Problems Crack (1135); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the tubing of seventeen (17) homechoice automated pd sets with cassette were damaged near the junction between the cassette and the tubing lines.The damaged tubing lines were further described as cuts or cracks on the tubing near the cassette.The damaged supplies were discovered before patient use for peritoneal dialysis therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

B5: during follow up, it was clarified that thirty (30) cassettes were damaged.H10: the actual device was not available; however, three (3) photographs of the samples were provided for evaluation.Visual inspection was performed and a surface mark was observed on the last fill line tubing located at the port of the cassette.This surface mark was caused by the grippers during the automation assembly and not considered a defect.The reported condition was not verified.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: 11285897
• MDR Text Key: 231789656
• Report Number: 1416980-2021-00424
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00085412087375
• UDI-Public: (01)00085412087375
• Combination Product (y/n): Y
• PMA/PMN Number: K923065
• 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: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C4469C
• Device Lot Number: H20C11056
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1