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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Phone number: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during continuous renal replacement therapy (crrt) with a prismax machine equipped with a thermax blood warmer, a minor external blood leak was observed from the luer lock connection between the thermax disposable and the return blood line of the prismaflex st150 set, resulting in a small blood clot.The treatment was ended and the extracorporeal blood was returned to the patient.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
G1: address line 1: (b)(6).H10: the device and two pictures were received for evaluation.The visual analysis of the picture confirmed the presence of coagulated blood at the connection between the prismaflex set (male luer connector) and thermax bag (female luer connector).Visual inspection of the actual sample observed clotted blood at the level of the connection indicating a minor blood leak.No defects were observed.The connection was redone and a functional test (pressure test) was performed and no leak or air inlet was observed.The cause of the condition could be attributable to a bad connection between the return line of the set and the thermax by the user.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; see h10; n suite 170; montrevel-en-bresse MN 01340 ; FR 01340
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 14522027
• Report Number: 1416980-2022-02692
• Device Sequence Number: 6428907
• Product Code: KDI
• UDI-Device Identifier: 07332414123932
• UDI-Public: (01)07332414123932
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Followup
• Report Date (Section B): 07/29/2022

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: 03/05/2024
• Device Catalogue Number: 955516
• Device Lot Number: 21C05
• 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: 05/02/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 07/29/2022
• 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: PRISMAFLEX ST150 SET; PRISMAX MACHINE; THERMAX BLOOD WARMER
• Patient Sex: Unknown