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 04/30/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the heater bag line of a kaguya set disconnected from the cassette.This was identified following testing of a peritoneal dialysis (pd) cycler.This was further described as, upon completion of a test therapy, the cassette was removed from the (pd) cycler and the heater bag line (tubing) disconnected from the cassette component.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information : the device was received for evaluation.A visual inspection was performed, and it was 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 was inserted fully into the port.This was evidence that there is no issue related to the manufacturing process that resulted in this separation of the heater bag line tubing from the welded cassette sub-assembly.An underwater pressure test also performed with no issues noted.The reported condition was verified.The cause of the condition was undetermined.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.

• 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: 8656501
• MDR Text Key: 146650465
• Report Number: 1416980-2019-02977
• 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,Followup
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• 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: 05/24/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2019
• 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