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 Fatigue (1849); Peritonitis (2252)

Event Date 03/21/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of all batch record documents was performed for potentially associated lot number h13l11065, h14a14052, and h14b17103 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.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced and was hospitalized for peritonitis coincident with therapy for peritoneal dialysis.The patient had been in and out of the hospital for fatigue prior to being diagnosed with peritonitis.The symptom of fatigue was considered a manifestation of the peritonitis.The patient was treated with vancomycin intraperitoneally (dose and frequency not reported) for the event and was discharged from the hospital three days after admittance.At the time of this report, the patient was reported to be recovering from the peritonitis.Therapy was ongoing.No additional information is available at this time.This is report 1 of 2 involved in this event.

Manufacturer Narrative

(b)(4).A batch review will be performed for potentially associated lot numbers h13l11065, h14a14052, and h14b17103.Should relevant additional information become available pertaining to the reported event, a follow-up report will be submitted.This is the same patient as (b)(4).

• 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: 3773799
• MDR Text Key: 12100101
• Report Number: 1416980-2014-13401
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2014

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
• Device Catalogue Number: L5C4531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/31/2014
• Initial Date FDA Received: 04/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/25/2014
• 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: DIANEAL AMBUFLEX; MINICAP; DIANEAL ULTRABAG; HOMECHOICE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR