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	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported an external blood leak was observed from a thermax blood warmer disposable.Thirty minutes into continuous renal replacement therapy the leak was observed from the luer lock connection between the thermax disposable and the return blood line of the prismaflex hp-x set.Treatment was discontinued without blood restitution and the accumulated blood loss was 192ml.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
E1: (b)(6).H4: device manufacture date: the device was manufactured between (b)(6) 2023 and (b)(6) 2023.H10: the device was received for evaluation attached to the prismaflex hp-x set.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Traces of coagulated blood were observed on the luer connector between the thermax and return line.This connection has been isolated from the rest of the assembly, without manipulating the connection between the two devices (connection made by the customer) so as not to alter it.An air leak test was performed (0.5bar) and a leak was observed at the level of the luer connection.The reported condition was verified.Upon disconnecting the thermax and the return line, no anomaly was noted at the connectors luers.The connection between the prismaflex hp-x set and the thermax warmer bag was restored, and an air leak test was performed (0.5bar).No leak was observed.The cause of the condition could not be determined.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: 17691138
• Report Number: 1416980-2023-04499
• Device Sequence Number: 12273165
• Product Code: KDI
• UDI-Device Identifier: 37332414123933
• UDI-Public: (01)37332414123933
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/06/2023

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 Catalogue Number: 955516
• Device Lot Number: 23C06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 09/06/2023
• 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: PRISMAFLEX HP-X SET.; PRISMAX MACHINE.; THERMAX BLOOD WARMER.
• Patient Sex: Unknown