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

Catalog Number N5C8305C

Device Problems Fluid/Blood Leak (1250); Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that two (2) homechoice low recirculation volume apd cassettes had holes in the patient line which resulted in leaks.The leaking was discovered while the patient was connected for treatment.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Describe event or problem: there was no patient injury, however, the patient received prophylactic treatment due to the event.(previously reported as no medical intervention associated with this event).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; 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: 8191504
• MDR Text Key: 131227776
• Report Number: 1416980-2018-07991
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102936
• 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,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/16/2023
• Device Catalogue Number: N5C8305C
• Device Lot Number: H18H16033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 01/03/2019; 02/01/2019
• Supplement Dates FDA Received: 01/04/2019; 02/26/2019
• 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
• Treatment: UNSPECIFIED PD SOLUTION
• Patient Age: 9 YR