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

Catalog Number	5C4476
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the effluent sample bag leaked; further described as ¿fluid was leaking out of the port¿.This occurred during an unspecified process step of peritoneal dialysis therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H10: one actual sample was received for evaluation.A visual inspection with the naked eye noted a channel leak on the outer sides of the two ports at the radio-frequency (rf) weld.Functional testing including leak testing, clear passage testing and clamp function testing were performed and a leak was noted.The reported condition was verified.The cause of the event was determined to be manufacturing related.A nonconformance has been opened to address this issue.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: EFFLUENT SAMPLE BAG
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10771763
• Report Number: 1416980-2020-06792
• Device Sequence Number: 19117069
• Product Code: FKX
• UDI-Device Identifier: 00085412007717
• UDI-Public: (01)00085412007717
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K923065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/15/2024
• Device Catalogue Number: 5C4476
• Device Lot Number: H19J15056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TITANIUM ADPATER.; TRANSFER SET.; TITANIUM ADPATER; TRANSFER SET