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

Catalog Number R5C4479C

Device Problem Insufficient Information (3190)

Patient Problems Peritonitis (2252); Complaint, Ill-Defined (2331)

Event Date 05/06/2014

Event Type  Injury  

Event Description

It was reported that a patient experienced bacterial peritonitis manifested by cloudy effluent bag coincident with peritoneal dialysis (pd) therapy.The next day, the patient started treatment with vancomycin (dose, route, frequency, and duration not reported) and gentamicin (dose, route, frequency, and duration not reported) as a prophylaxis treatment for peritonitis.On the same day, treatment with vancomycin and gentamycin was stopped.The cause of the peritonitis event was unknown.Three days after the onset of peritonitis, the patient was hospitalized.Further treatment for the peritonitis event was not reported.Hospitalization was reported as ongoing.At the time of this report, the patient was recovering from peritonitis.On the day of hospitalization, dianeal therapy was discontinued due to the peritonitis event and hemodialysis was started.No additional information is available.This is report 1 of 4.

Manufacturer Narrative

(b)(4).This report involves the same patient as in (b)(4).The device was not returned; therefore, a device analysis could not be completed.Should the device be returned or additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).A review of all batch record documents was performed for potentially associated lot numbers h14b08037 and h14a25017 with no issues noted during the manufacturing process.There were no deviations from standard procedure and no exceptions related to the reported condition.Should additional relevant information become available, a follow-up 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: 3873001
• MDR Text Key: 4591944
• Report Number: 1416980-2014-18938
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: R5C4479C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2014
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD); DIANEAL 2.5% LOW CALCIUM ULTRABAG PD4, MINICAP,; TRANSFER SET, FLEXICAP
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR