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

Catalog Number 5C8310

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient (pt) who performs pd therapy with a homechoice (hc) device experienced discomfort, further described as chest pains, diaphragm pain, and arm pain after completing therapy with the hc device.It was further described that the pt experienced the symptoms after an initial drain.During this experience, the hc device did not have any alarms.Due to the event, the pt went to the emergency room (er).During the er visit, the pt received 2 morphine injections through an iv (intravenous access) and was subsequently discharged home after being evaluated and treated.Due to the symptoms, the pt was placed on manual capd (continuous ambulatory pd) therapy.The pt stated that yesterday, she tried to use her hc machine again, and had similar symptoms as before, but not as intense.The pt is currently on capd therapy.At the time of this report, the pt is doing better.Additional information was requested but is not available.

Manufacturer Narrative

(b)(4).The reported symptoms of chest pains, diaphragm pain, and arm pain occurred on an unknown date in (b)(6) 2014 and the pt went to the er for the symptoms on an unknown date in (b)(6) 2014.Should additional relevant information become available, a follow-up will be submitted.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.The device has not been previously serviced.A review of the device history revealed no nonconformities, failures, rework or deviations that would cause or contribute to the reported problem.There was no non-conforming product identified related to the reported problem.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE PRO
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY PRODUCTCODE
• 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: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3957656
• MDR Text Key: 4555485
• Report Number: 1416980-2014-24207
• 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: 07/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• 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?: No
• Date Manufacturer Received: 08/13/2014
• 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
• Patient Outcome(s): Required Intervention