MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION THERMAX BLOOD WARMER DISPOSABLE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	955516
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter postal code: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a blood leak was observed originating at the connection between the thermax blood warmer disposable and a prismaflex st150 set during continuous renal replacement therapy.The leak was ¿towards the air separation chamber".The volume of blood loss was approximately 200ml.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H10: the prismaflex st 150 set and thermax blood warmer disposable were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.There is coagulated blood at the level of the connection between the thermax and the warmer connection.After rinsing the line and the thermax bag, a leak test was performed under water.No leak was observed at the level of the connection.After disconnecting and reconnecting the warmer connection with the thermax bag, a second leak test was performed under the water.No leak was observed at the level of the connection.The reported condition was not verified.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: THERMAX BLOOD WARMER DISPOSABLE
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ECM - LIDER SAS; 92 rue des treize vents; montrevel-en-bresse 01340 ; FR 01340
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17817932
• Report Number: 1416980-2023-04862
• Device Sequence Number: 2480434
• Product Code: KDI
• UDI-Device Identifier: 37332414123933
• UDI-Public: (01)37332414123933
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K190910
• 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): 11/17/2023

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: 02/04/2026
• Device Catalogue Number: 955516
• Device Lot Number: 23B04
• 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: 08/29/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2023
• 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: PRISMAFLEX ST150 SET.; PRISMAX MACHINE.
• Patient Sex: Unknown