MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION REVACLEAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	114746L
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that 10 minutes into hemodialysis treatment using a revaclear 400, an "external leakage" as well as "severe blood leak alarm" alarm were generated.Approximately 1/2 ml of blood was observed leaking out of the top of the dialyzer.Treatment was immediately stopped and blood was not returned to the patient.The patient was disconnected from the lines and the machine.Ancef (2g) was given to the patient post dialysis per doctor orders.There was patient involvement however, no patient injury or medical intervention was reported.No additional information is available.
Additional Manufacturer Narrative
Additional information: d9, h3, h6 and h10.The actual sample and two pictures were received for investigation.An internal blood leak into the dialysate path was observed on the sample, however, no external leak from the dialyzer was observed.The cause of the internal blood leak was found to be from the incorrect placement of a gasket inside of the dialyzer, where the blood was seeping through the support ring of the dialyzer.There were also two photos attached to the record and they were visually inspected.The first photo observed was a dialyzer that was connected to the tubing that was being used during patient therapy.There looked to be blood leaking internally in the dialysate path, with the blood looking to be slipping through the support ring of the dialyzer.The second photo showed the dialyzer from the first photo, just at a different angle.The photos were indicative of an internal blood leak, not an external blood leak.The caused was manufacturing related.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: REVACLEAR
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - OPELIKA; 1101 jeter ave; opelika AL 36801
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15677814
• Report Number: 3006552611-2022-00017
• Device Sequence Number: 2415024
• Product Code: KDI
• UDI-Device Identifier: 07332414124076
• UDI-Public: (01)07332414124076
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K130039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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: Health Professional
• Device Expiration Date: 01/04/2025
• Device Catalogue Number: 114746L
• Device Lot Number: C422200501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ANCEF 2 GRAMS
• Patient Sex: Unknown