MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number R5C4479

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2015

Event Type  malfunction  

Event Description

It was reported that a homechoice device experienced a system error 2240 (air in line/set) alarm.The patient was connected at the time of the alarm.This occurred during dwell five of peritoneal dialysis therapy.The patient noticed fluid on the table.The patient stated they would complete therapy using manual supplies.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device was returned and an evaluation is complete.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed by running the device on a lab homechoice with no issues noted.The device operated within specifications and no defect was found.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE AUTOMATED PD SET WITH CASSETTE
• 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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4765900
• MDR Text Key: 5793751
• Report Number: 1416980-2015-21009
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/25/2018
• Device Catalogue Number: R5C4479
• Device Lot Number: S14K22089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: HOMECHOICE