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

Catalog Number 112466

Device Problem Fluid/Blood Leak (1250)

Patient Problems Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Nausea (1970); Malaise (2359); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/25/2023

Event Type  Injury  

Event Description

It was reported during hemodialysis with a polyflux 170h set, an internal blood leak was observed.It was not reported if the unspecified dialysis machine alarmed.Internal blood leaks are limited to the volume contained in the extracorporeal (ec) circuit which corresponds to 5 -10 % of the patient¿s blood volume.This would not be expected to result in any significant patient harm; however, this patient was hospitalized.No further information was available at the time of this report.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

B5: upon additional information, the patient experienced shortness of breath, which occurred prior to the internal leak.Hemodialysis therapy was paused, and oxygen (o2) therapy was provided.The blood pressure was 195/99mmhg, hr 55/min, blood oxygen was at 98%.After five minutes the symptoms subsided, and treatment resumed with the patient remaining on 14l of o2.After an unspecified amount of time, the patient started to ¿feel sick and nauseous¿.The patient was treated with omeprazole and nifedipine; however, the symptoms did not abate.Therapy lasted about one and a half hours and was stopped prior to the planned time.No further information was available at the time of this report.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the provided photographic sample showed only the monitor and not the related blood leak.The reported condition was not verified.Due to the nature of the provided samples, no further testing could be performed.Therefore, a device analysis could not be completed.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: POLYFLUX
• Type of Device: 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: 17995740
• MDR Text Key: 326381521
• Report Number: 9611369-2023-00217
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414102760
• UDI-Public: (01)07332414102760
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 112466
• Device Lot Number: 2-4504-H-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 11/16/2023
• Supplement Dates FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED DIALYSIS MACHINE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female