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

Catalog Number T5C4600

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that "all lines" were disconnected from the kaguya set.This occurred after a demonstration on the kaguya machine was performed by the nurse.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.Visual inspection was performed and it was noted that all the lines had separated from the welded cassette subassembly.Solvent residue was present in the tubing and the tubing showed evidence that it had been inserted fully into the port during the manufacturing process.An underwater pressure test was also performed with no issued noted.The reported condition was verified.The cause of the reported condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOME PD SYSTEM KAGUYA SET
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; singapore
• MDR Report Key: 8337093
• MDR Text Key: 136114291
• Report Number: 1416980-2019-00795
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: T5C4600
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Initial Date Manufacturer Received: 01/16/2019
• Initial Date FDA Received: 02/13/2019
• Supplement Dates Manufacturer Received: 02/18/2019
• Supplement Dates FDA Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1