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

Catalog Number 5C8310R

Device Problem Insufficient Information (3190)

Patient Problem Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

(b)(4).On an unknown date approximately six months prior to the receipt of this report, the patient experienced a hernia.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported the patient experienced a hernia coincident with automated peritoneal dialysis therapy.It was not reported if the hernia occurred after beginning automated peritoneal dialysis therapy or prior to initiating automated peritoneal dialysis therapy.The cause of the hernia was not reported.It was not reported if the hernia worsened with peritoneal dialysis therapy.The patient was not hospitalized for the event.Treatment for the hernia event was not reported.The care plan for the event was that the patient would be visiting the physician on an unknown date and be evaluated for any treatment/action on the hernia.Dianeal therapy was ongoing.The patient was not recovered from the event.No additional information is available.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation; therefore a device analysis could not be performed.The service history revealed no repetitive failures, no workmanship or process issues, and no similar complaints related to the reported problem.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).On an unreported date, the patient underwent outpatient surgery as a treatment of the hernia.At the time of this report the patient was recovering from this hernia event.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 - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer (Section G): BAXTER HEALTHCARE - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5153434
• MDR Text Key: 28411875
• Report Number: 1416980-2015-39045
• 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: company representative,consum
• Reporter Occupation: Nurse
• Type of Report: Followup,Followup
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• 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?: Yes
• Date Manufacturer Received: 11/18/2015
• 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
• Patient Outcome(s): Other; Required Intervention