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 Death (1802); Heart Failure (2206); Peritonitis (2252)

Event Date 05/29/2014

Event Type  Death  

Manufacturer Narrative

(b)(4).The patient was discharged from the hospital on (b)(6) 2014 (previously reported as (b)(6) 2014).During follow up, failure to thrive was reported as an additional cause of death.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced peritonitis and eventually passed away coincident with peritoneal dialysis (pd) therapy.The cause of the peritonitis is unknown.The patient was hospitalized the same day as the onset of peritonitis.The patient was treated with an unspecified antibiotic (dose, route and frequency not specified) for the peritonitis.Four days after hospitalization, the patient was discharged and was reported to be recovering from the peritonitis.The patient passed away three weeks after being discharged from the hospital for the peritonitis event.The cause of death was reported to be heart failure.Pd therapy was ongoing until the time of death.An autopsy was not performed.No additional information is available.This is report 2 of 2 involved in this event.

Manufacturer Narrative

Complaint no: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.This is the same patient as cmplnt (b)(4).

Manufacturer Narrative

(b)(4).A batch review was conducted for potentially associated lot number h14c20105.There were no issues detected during the manufacturing process.As the sample was not returned, a device evaluation cannot be performed.Should additional relevant information become available, a supplemental 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: 3930921
• MDR Text Key: 16313790
• Report Number: 1416980-2014-22480
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2014
• 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?: No
• Date Manufacturer Received: 09/30/2014
• 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 PD2 ULTRABAG; MINICAP TRANSFER SET; DIANEAL PD2 AMBUFLEX; HOMECHOICE PRO
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 88 YR