MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EFFLUENT SAMPLE BAG; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	5C4476
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	Peritonitis (2252)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a connection issue between the peritoneal dialysis (pd) transfer set and effluent sample bag which resulted in peritonitis.While attempting to remove an effluent sample bag from the affected transfer set, it was observed that the female connector was coming loose from the light blue mainbody of the transfer set.The nurse was taking an effluent sample from the patient and was removing sample bag which was on so tight upon twisting noticed the blue tip of the transfer set was un-threading rather than the sample bag port.It was not reported if the patient was hospitalized for peritonitis.The patient was treated with unspecified intraperitoneal antibiotics (dose and frequency not reported) for peritonitis.At the time of this report, the patient outcome and action taken with pd therapy were not reported.The transfer set was replaced.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information was added to h6.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.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EFFLUENT SAMPLE BAG
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 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: 17768729
• Report Number: 1416980-2023-04708
• Device Sequence Number: 6273224
• Product Code: FKX
• UDI-Device Identifier: 00085412007717
• UDI-Public: (01)00085412007717
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• 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): 10/20/2023

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: Health Professional
• Device Expiration Date: 12/17/2025
• Device Catalogue Number: 5C4476
• Device Lot Number: H20L17030
• 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: 08/23/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/20/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRANSFER SET.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown