MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC ULTRASET CAPD DISPOSABLE DISCONNECT Y-SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	L5C4366
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Peritonitis (2252)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a peritoneal dialysis patient experienced a leak from an ultraset capd disposable disconnect y-set.It was further reported the patient noticed a hole on the set.The cause of the hole was unknown.Subsequently, the patient experienced peritonitis.Hospitalization, treatment, patient outcome and action taken with pd therapy were not reported.No additional information is available.
Additional Manufacturer Narrative
Correction d3: device manufacturer name: replace baxter healthcare corporation with baxter international inc.H11: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.A medical safety review was performed with the event seriousness conclusion being serious injury.Peritonitis is an infection that requires medical intervention and will be assessed as a serious injury.It is unclear from the report whether the alleged malfunction of the capd y-set caused or contributed to peritonitis for the patient.The review concluded that it is undetermined whether use of the capd y-set caused or contributed to peritonitis.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ULTRASET CAPD DISPOSABLE DISCONNECT Y-SET
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER INTERNATIONAL INC; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19629209
• Report Number: 1416980-2024-03264
• Device Sequence Number: 8535396
• Product Code: KDJ
• UDI-Device Identifier: 00085412090085
• UDI-Public: (01)00085412090085(10)H24B15014(17)260215
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K961825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/15/2026
• Device Catalogue Number: L5C4366
• Device Lot Number: H24B15014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female