MAUDE Adverse Event Report: BAXTER HEALTHCARE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Device Problem Insufficient Information (3190)

Patient Problems Swelling (2091); Complaint, Ill-Defined (2331)

Event Date 03/10/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not available for evaluation.If additional relevant information is obtained, then a follow-up mdr will be submitted.

Manufacturer Narrative

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

Event Description

It was reported a patient experienced and was hospitalized for ¿heart issues and fluid in the body¿ coincident with peritoneal dialysis (pd) therapy on the homechoice (hc).Treatment was not reported.The cause of the ¿heart issues and fluid in the body¿ was unknown.At the time of this report the outcome of ¿heart issues and fluid in the body were not reported¿.Additional information was requested but is not available.

• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE
• Manufacturer (Section G): BAXTER HEALTHCARE
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3728014
• MDR Text Key: 11897973
• Report Number: 1416980-2014-11058
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/30/2014
• Initial Date FDA Received: 04/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2014
• 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): Hospitalization