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

Catalog Number BBC8314P

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a homechoice cassette was missing the cap from the drain line.This was found before use of the device.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The actual device was received for evaluation.A visual inspection performed with the naked eye revealed the drain line was missing the cap.Marks on the drain line were identified which a cap produces when it is placed in the tubing.The tubing of the drain line where the cap is placed was measured with no issues noted.The reported condition was confirmed.The direct cause of the condition could not be determined.Twelve (12) retention samples were also visually inspected with no issues noted.The reported condition was not verified on the retention samples.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 - ATLACOMULCO; atlacomulco
• MDR Report Key: 8448839
• MDR Text Key: 139817037
• Report Number: 1416980-2019-01572
• Device Sequence Number: 1
• Product Code: FKX
• 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: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/02/2024
• Device Catalogue Number: BBC8314P
• Device Lot Number: 01AAHC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Date Manufacturer Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HOMECHOICE