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

Catalog Number 5C4471R

Device Problem Leak/Splash (1354)

Patient Problems Swelling (2091); Rupture (2208); Hernia (2240); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient who performed therapy with a homechoice device (hc) experienced a hernia and peritoneal leak.On an unreported date, the patient was hospitalized for swollen testicles.The patient indicated that the hydroseal of the peritoneal sac was ruptured during therapy resulting in swelling of the scrotum.During the hospitalization, the patient was diagnosed with a hernia and a leak in the peritoneal area (right lower quadrant below the umbilical area).Six days prior to the receipt of this report, the patient underwent a repair of the hernia.At the time of this report, the patient was not performing pd therapy as he was placed on temporary hemodialysis to allow for healing.No additional information is available.

Manufacturer Narrative

(b)(4).The device evaluation has begun but has not yet been completed.Should additional relevant information become available, a follow-up will be submitted.

Manufacturer Narrative

(b)(4).The device was received for evaluation by the baxter product analysis laboratory (pal).A review of the service history and the event history log was performed.The review of service history did not identify any previous servicing events that could have contributed to the reported issue of hernia.Review of the device logs did not reveal any issues that could be related to the reported issue.There were no keystrokes, no device failure, malfunction, programming, use related or iipv (increased intraperitoneal volume) events that would indicate and/or contribute to the reported issue.The device was tested and passed both the homechoice return instrument test/ evaluation (rite) functional test and the rite electrical test.The device was determined to meet functional and electrical performance specification requirements.An external and internal inspection was performed which revealed no anomalies.An evaluation of the device pneumatic system revealed no leak and all pressures were correct and stable.The device passed seal, purge and wet disposable integrity tests.A short simulated therapy was performed successfully.Per pal evaluation, there was no failure, malfunction or iipv event identified that could have caused or contributed to the reported issue of hernia.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE
• 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: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3926063
• MDR Text Key: 4495886
• Report Number: 1416980-2014-22007
• 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: 06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C4471R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2014
• 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; Required Intervention
• Patient Weight: 95