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

Catalog Number 5C8310

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Malaise (2359)

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A peritoneal dialysis (pd) patient experienced, difficulty draining, difficulty breathing and did not feel well during an unknown process step of automated peritoneal dialysis.At the time of the events, the home patient was not connected.The cause of the events was unknown.The nurse advised the patient¿s caregiver that the device was not working properly (not further specified).The patient was taken to the emergency room and was admitted to the hospital.It was not reported if the patient received medical intervention.No further detail was provided regarding the patient¿s outcome from the event.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.Internal and external inspection was performed and no issues were noted.The device¿s pneumatic system was tested and no leaks were detected; all pressures were correct and stable.There were no problems found during an internal inspection; all connections were correct and secure.The homechoice device received a returned instrument testing evaluation (rite).This evaluation included functional and electrical testing of the device.The device was determined to meet functional and electrical performance specification requirements per rite testing.The sample analysis revealed no device malfunction that could have caused or contributed to the reported problem.The reported condition was not verified.The cause of the condition could not be determined.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; largo FL
• Manufacturer (Section G): BAXTER HEALTHCARE - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7653077
• MDR Text Key: 112836357
• Report Number: 1416980-2018-03974
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C8310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization