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

Catalog Number MRM4431P3

Device Problem Material Puncture/Hole (1504)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Event date: this occurred on an unspecified date in 2020.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that two (2) homechoice cassettes presented a hole from an unspecified location.This was observed during "self-test".There was no patient involvement.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, eighteen (18) companion samples were received for evaluation.A visual inspection with naked eye was performed with no issues noted.Since the actual sample was not received, the reported issue could not be confirmed or refuted, therefore the cause could not be determined.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: 9981914
• MDR Text Key: 188538146
• Report Number: 1416980-2020-02282
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 05413765562433
• UDI-Public: (01)05413765562433
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MRM4431P3
• Device Lot Number: SE19JB2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1