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

Catalog Number 5C8310R

Device Problem Filling Problem (1233)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A service history review showed no failures/problems that were the same as, or similar to, the current difficulty.In addition, there was no indication that the parts replaced during servicing caused or contributed to the reported difficulty.Should additional relevant information become available, a follow-up report will be submitted.

Event Description

It was reported that the home patient (hp) using a home choice (hc) contacted customer service regarding not getting the last fill.The hp usually gets off the hc and manual drains four hours later.The hp attempted to drain and nothing came out.The hp weighed the drain bag and it was 13l.The fluid remaining on the cycler was 1l.The initial drain volume (idv) was 3ml.The last fill volume (lfv) was 1498ml.The total fill volume (tfv) was 9591ml.The total drain volume was 10,358ml.There were no manual drains logged.There were also no alarms and no bypasses.The technical service representative (tsr) explained that the scale could be out of calibration.The tsr also explained that the hp could have a blockage.No patient injury or medical intervention was indicated as a result of this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device was determined to meet functional and electrical performance specification requirements.The device passed rite functional testing and the electrical test.External and internal inspection was passed, and a check of pneumatic system found all pressures to be stable and correct.A short simulated therapy was completed successfully.Review of the device logs did not verify the reported issues; review of the event log on the date of the reported complaint showed the home patient received a last fill volume of 1498ml.Manual drain volumes would not be recorded in the device logs.The cause for the reported issue of the home patient not receiving their last fill volume was undetermined.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: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3804141
• MDR Text Key: 12061469
• Report Number: 1416980-2014-15182
• 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: 04/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C8310R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2014
• 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 Age: 53 YR