MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 5C8302C

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Event date: on an unspecified date in 2019.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a low recirculation homechoice set with cassette was cracked.Before use for peritoneal dialysis (pd) therapy, it was discovered that the cassette was cracked ¿between the rigid and flexible part¿.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information : the device was discarded and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - MOUNTAIN HOME; mountain home AR
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8951614
• MDR Text Key: 160016740
• Report Number: 1416980-2019-04758
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K012988
• 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: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C8302C
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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