MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE HOMECHOICE PRO; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 5C8310

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

Patient Problems Myocardial Infarction (1969); Heart Failure (2206)

Event Type  Death  

Event Description

It was reported that a patient experienced cardiac disease, cardiac failure, and myocardial infarction and subsequently died due to the events coincident with peritoneal dialysis (pd) therapy.On an unknown date in the month prior to the month of death, the patient was admitted to the hospital with cardiac and respiratory arrest.The patient was intubated and placed on a ventilator.All other treatment received by the patient was unknown.On an unknown date during hospitalization, pd therapy was discontinued and the patient was placed on hemodialysis due to the patient¿s ¿worsening status.¿ it was reported that the patient had an extensive history of cardiac issues.The patient did not recover from the events.Subsequently, the patient passed away in the hospital.The cause of death was ¿worsening cardiac disease¿, cardiac failure and heart attack.It was not reported whether an autopsy was performed.No additional information is available.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.The device was not returned for evaluation.A device history record review revealed no issues that could have caused or contributed to the reported event of death.As a result, the cause of the event could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE PRO
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 4323997
• MDR Text Key: 5212727
• Report Number: 1416980-2014-45239
• 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: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C8310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DIANEAL PD4, 2.5% AMBUFLEX
• Patient Outcome(s): Death; Hospitalization; Required Intervention