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

Catalog Number L5C4531

Device Problem Insufficient Information (3190)

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

Event Date 06/06/2014

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient was suspected to have experienced peritonitis.In the month prior to the receipt of this report, the patient was hospitalized for another indication for 24 days.On an unknown date, the patient had "stagnant effluent" due to poor drainage and was treated with ancef ip (dose and frequency not reported) prophylactically for peritonitis.The cause of the suspected peritonitis was unknown.At the time of this report, the patient had completed the antibiotics and was fully recovered from the peritonitis event.Pd therapy was ongoing.Additional information was not available.This is report 2 of 3 involved in this peritonitis event.

Manufacturer Narrative

Complaint no: (b)(4).As the sample was not returned and the lot number is unknown, a device evaluation cannot be completed.Should additional relevant information become available, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

(b)(4).A batch review was conducted on lot h14d21036 and there were no deviations from standard procedure and no exceptions related the reported condition were noted.Should additional relevant information become available, a follow-up 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: 3980487
• MDR Text Key: 19768747
• Report Number: 1416980-2014-25346
• 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: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• 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: 10/01/2014
• 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: MINICAP, MINICAP TRANSFER SET, HOMECHOICE; DIANEAL PD4 1.5% AND 2.5% AMBUFLEX
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR