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 Dehydration (1807); Peritonitis (2252); Constipation (3274)

Event Date 07/03/2014

Event Type  Injury  

Event Description

It was reported that the patient experienced peritonitis coincident with peritoneal dialysis therapy.The peritonitis was manifested by dehydration and constipation.The cause of the peritonitis event was believed to be constipation; however this could not be medically confirmed.The patient was hospitalized for the reported event.The patient was treated with intraperitoneal gentamycin (dose, route and frequency unknown).The patient was discharged from the hospital within four days of admission.At the time of discharge the dehydration and constipation had been resolved.The patient was recovering from the peritonitis.The pd therapy was ongoing.Additional information was requested and was not available at this time.This is report 4 of 4.

Manufacturer Narrative

(b)(4).The reported product is an unknown cassette.As the sample was not returned and the lot number is unknown, a device analysis cannot be completed.Should additional relevant information become available, a follow up report will be submitted.(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: 4182968
• MDR Text Key: 16562297
• Report Number: 1416980-2014-36419
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/22/2014
• Initial Date FDA Received: 10/17/2014
• 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: HOMECHOICE PRO; DIANEAL AMBUFLEX PD4 1.5%; DIANEAL AMBUFLEX PD4 2.5%; TITANIUM ADAPTER, MINICAP, TRANSFER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR