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

Catalog Number	114745
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hemolysis (1886); High Blood Pressure/ Hypertension (1908); Hematuria (2558)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during treatment with a reva clear 300 dialyzer, the patient experienced severe abdominal pain and increased blood pressure.The treatment was stopped at an unknown stage.After treatment the patient experienced hemolysis and blood in the urine.The dialyzer was not reused and no other product defects were observed.Treatment for the events were not reported.For four days the patient was briefly treated in the intermediate care unit and was in domiciliary care.The patient underwent dialysis with a non-baxter dialyzer in the hospital and was treated with non-baxter equipment in inpatient care.No further issues were noted.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: b1, d19, h1, h3, h6, h11.H11: the device was received for evaluation.Visual inspection of the sample with naked eyes shows the product contaminated.After disinfection, the product shows no issues noted.No findings are visible when inspecting the cutting surface of the product.The measurements of the inner diameters were within the specification.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was not verified, the cause of the condition could not be determined.Based on additional information received, the revaclear dialyzer was determined not to be a factor in the reported adverse event.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 - HECHINGEN BADEN DIALYZER; holger - crafoord - strasse 26; hechingen D-723 79; GM D-72379
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20170127
• Report Number: 9611369-2024-00157
• Device Sequence Number: 8031878
• Product Code: KDI
• UDI-Device Identifier: 07332414114916
• UDI-Public: (01)07332414114916(10)3-9213-H-01(17)260930
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 114745
• Device Lot Number: 3-9216-H-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: AK 98 V2 230V; NOVALINE BL 207; WRO 300 DEVICE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female