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

Catalog Number BBC8314P

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2019

Event Type  malfunction  

Manufacturer Narrative

Report source: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a homechoice cassette had the membrane that presented "a little perforation".This was noticed before use.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

One (1) actual sample was received opened in the primary package.A visual inspection with the naked eye noted a mark on the sheeting.Leak testing was performed with no issues noted.The reported condition was verified as a mark on the returned device.The cause of the condition could not be determined.Twelve (12) retention samples were evaluated at the facility.A visual inspection with the naked eye was performed 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
• Manufacturer (Section G): BAXTER HEALTHCARE - ATLACOMULCO; av. ing. salvador sanchez; colin no. 9; atlacomulco CP504 50; MX CP50450
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8478971
• MDR Text Key: 140793164
• Report Number: 1416980-2019-01771
• Device Sequence Number: 1
• Product Code: FKX
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/18/2023
• Device Catalogue Number: BBC8314P
• Device Lot Number: 14ZLHC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1