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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Tachycardia (2095); Weakness (2145); Peritonitis (2252); Malaise (2359)

Event Date 10/01/2014

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient experienced bacterial peritonitis.The peritonitis was manifested by not feeling well, tachycardia, fever of 102 degrees, and weakness.The cause of peritonitis was unknown.The patient was hospitalized for the event.The patient was treated with unknown oral antibiotics (dose, and frequency were unknown), intraperitoneal (ip) vancomycin (dose and frequency not reported), ip and intravenous (iv) cefazolin (dose and frequency not reported) and gentamycin (dose and frequency not reported) for peritonitis.At the time of this report, the patient was recovering from the peritonitis event.The patient had not been retrained on aseptic technique.Pd therapy was ongoing.Additional information was not available.This is report 2 of 3 involved in this peritonitis event.

Manufacturer Narrative

(b)(4).The reported product is an unknown baxter cassette.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.Same patient as (b)(4).

• 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: 4216677
• MDR Text Key: 5000340
• Report Number: 1416980-2014-38125
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2014
• 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: TRANSFER SET, MINICAP, HOME CHOICE,; DIANEAL PD4 1.5% AMBUFLEX, EXTRANEAL,
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR