MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME EXTENSION SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	5C4464P
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that two (2) patient extension sets were leaking from an unspecified location.This occurred during unspecified process steps of peritoneal dialysis therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information :it was reported that two (2) "patient" (drain line) extension sets were leaking from an unspecified location.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: EXTENSION SET
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - MOUNTAIN HOME; mountain home AR
• MDR Report Key: 8871937
• Report Number: 1416980-2019-04334
• Device Sequence Number: 1829023
• Product Code: FKX
• UDI-Device Identifier: 00085412030555
• UDI-Public: (01)00085412030555
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K833065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/29/2024
• Device Catalogue Number: 5C4464P
• Device Lot Number: H19D29091
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR