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

Catalog Number T5C4600

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation without a pouch.A visual inspection was performed with the naked eye which noted that the heater bag line (tubing) was separated from the welded cassette sub-assembly.There was solvent residue present in the tubing and the deformed tubing shape showed the tubing had been inserted fully into the port during the manufacturing process.An underwater pressure test was performed with no issues noted.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the heater bag line of a home pd system kaguya set disconnected (separated) from the cassette during laboratory testing.The engineer reported that when the cassette was removed from the cycler, the heater bag line disconnected from the cassette.There was no patient involvement.No additional information was 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: 8446349
• MDR Text Key: 139901337
• Report Number: 1416980-2019-01546
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00085412153278
• UDI-Public: (01)00085412153278
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/06/2023
• Device Catalogue Number: T5C4600
• Device Lot Number: S18E06032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Date Manufacturer Received: 02/25/2019
• 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