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

Catalog Number 5C8310R

Device Problem Leak/Splash (1354)

Patient Problems Hernia (2240); Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

(b)(4).As the device was not linked to the reported event until after the device had been routed to service, a complete device analysis could not be completed to investigate the reported event.However, a review of the device logs revealed no system errors, anomalies, hardware device failures or intraperitoneal volume iipv events that could have caused or contributed to the reported difficulty.A review of the service history revealed no previous service events that would cause or contribute to the reported event.Upon conclusion of the evaluation, the direct cause of the reported event was undetermined.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a peritoneal dialysis (pd) patient (pt) experienced a hernia, another developing hernia, bulging abdomen, and an unspecified abdominal leak coincident with pd therapy with a homechoice (hc) device.It was reported that the hernia (unspecified location) started while the pt was performing pd therapy.About one month prior to the receipt of this report, the pt was hospitalized for repair of the hernia.On an unknown date, during the hospitalization, pd therapy was discontinued for a week due to the hernia repair and during this time, no dialysis was performed due to the pt having some residual kidney function.Five days after being admitted, the pt was discharged from the hospital.Five days after being discharged, pd therapy with the hc was restarted but was not successful.As a result, the pt performed therapy using manual capd (continuous ambulatory pd) which worked well for about a week and a half.Three weeks after the date of hospital discharge, pd therapy was discontinued because the pt had an outpatient surgery to reposition the pd catheter to drain better with the hc cycler.During the outpatient surgery to reposition the catheter, a surgeon found another developing hernia (unspecified location) and fixed it with mesh.Following the surgery, an attempt to restart pd therapy with a small amount of pd solution (1900ml) was made, however, the pt¿s abdomen bulged and was only able to fill with 500ml.Therefore, pd therapy was held off.On an unknown date, after this attempt, another attempt to perform pd therapy was made while the pt was at the doctor¿s office.After filling with 2000ml, the pt only drained 1500ml.The pt was diagnosed with an unspecified abdominal leak.At the time of this event, the pt was not doing any dialysis until the pt would be seen by the surgeon regarding the leak (scheduled in 5 days).At the time of this report, the bulging abdomen and leak were ongoing.At the time of this report the pt was recovered from the hernia events.Additional information was requested but is not available.

Manufacturer Narrative

(b)(4).- the pt experienced a hernia on an unknown date in (b)(6) 2014.Should additional relevant information become available, a follow-up will be submitted.

• Brand Name: HOMECHOICE PRO
• 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: 3887042
• MDR Text Key: 12330527
• Report Number: 1416980-2014-19733
• 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: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Hospital Service Technician
• Device Catalogue Number: 5C8310R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2014
• 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 PD4, 1.5% AMBUFLEX; DIANEAL PD4, 2.5% ULTRABAG; DIANEAL PD4, 1.5% ULTRABAG; DIANEAL PD4, 2.5% AMBUFLEX
• Patient Outcome(s): Hospitalization; Required Intervention