MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE HOME PD SYSTEM KAGUYA SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number T5C4600

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

One sample was received without a pouch.Visual inspection was performed with naked eye and no abnormality was noted.Underwater pressure test at 8 psi was performed and no abnormality was observed for the sample received.The reported issue was not verified.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced a leak from the cassette of a home pd system kaguya set.This event occurred during connection.There was no patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: HOME PD SYSTEM KAGUYA SET
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; singapore
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; singapore 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7639093
• MDR Text Key: 112892604
• Report Number: 1416980-2018-03875
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: T5C4600
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1