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

Catalog Number L5C4531

Device Problem Invalid Sensing (2293)

Patient Problem Peritonitis (2252)

Event Date 12/16/2013

Event Type  Injury  

Event Description

It was reported that a patient experienced peritonitis coincident with peritoneal dialysis (pd) therapy.The patient was hospitalized on the same day for the event.The cause of peritonitis was unknown.On an unknown date, the patient was treated with vancomycin (ip, dose and frequency unknown) for peritonitis.Action taken with vancomycin was unknown.Three days after the onset of peritonitis and hospitalization, the patient was discharged from the hospital.The patient recovered from the peritonitis.Dianeal therapy was ongoing.No additional information is available.This is report 1 of 5.

Manufacturer Narrative

(b)(4).A review of all batch record documents was performed for potentially associated lot numbers h13i13025 and h13j10095 with no issues noted during the manufacturing process.There were no deviations from standard procedure and no exceptions related to the reported condition were noted.As the sample was not returned, a device analysis cannot be completed.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 - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3580186
• MDR Text Key: 4143082
• Report Number: 1416980-2014-01923
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: L5C4531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: HOMECHOICE, DIANEAL PD4 2.5% AND 4.25% AMBUFLEX; MINICAP, FLEXICAP, EXTENSION SET, TRANSFER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR