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

Catalog Number 5C8310R

Device Problem Human-Device Interface Problem (2949)

Patient Problems Chest Pain (1776); Dyspnea (1816); Pain (1994)

Event Date 12/08/2013

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient (pt) experienced difficulty breathing, fluid in lungs, chest pain, and pain shooting down the left leg while performing pd therapy on the homechoice (hc) device.The caregiver (cg) contacted a baxter technical service representative (tsr) to request assistance in performing a manual drain on the hc during use, during dwell cycle one.The cg explained that the pt was having trouble breathing for the last couple days and the cg wanted to take the pt to the hospital.The cg wanted to drain the pt first.The tsr assisted the cg with a manual drain and in ending the therapy session.On the same day, the pt was admitted to the hospital.On an unreported date, the pt received treatment for the events which included wearing special oxygen mask for (pap) positive airway pressure (either cpap- continuous or bipap-bilevel).At the time of this report, the pt remained hospitalized and dianeal therapy was ongoing.Additional information was requested but is not available.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a follow-up will be submitted.

Manufacturer Narrative

(b)(4).The device was manufactured in 2002.The device was not available for evaluation.A review of the device history revealed no issues that could have caused or contributed to the reported difficulty.A review of the service history revealed no failures or problems that were the same as, or similar to, the current difficulty and there was no indication that the parts replaced during servicing caused or contributed to the reported difficulty.If additional relevant information is received, a supplemental medwatch will be filed.

• Brand Name: HOMECHOICE PRO
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer (Section G): BAXTER HEALTHCARE - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3551129
• MDR Text Key: 4097503
• Report Number: 1416980-2014-00297
• 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
• Report Date: 12/09/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C8310R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2014
• 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 AMBUFLEX
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR