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

Catalog Number 114604

Device Problem Fluid/Blood Leak (1250)

Patient Problems Low Blood Pressure/ Hypotension (1914); Diaphoresis (2452)

Event Date 09/08/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).Initial reporter city :(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported the patient experienced hypotension and diaphoresis when connected to a u9000 ultrafilter set.Two hours into hemodialysis therapy, the patient¿s blood pressure read 80/50mmhg and the patient was noted to have a ¿large amount of sweat¿.Treatment was paused and the patient was treated with glucose (route and dose not provided).After an unspecified amount of time the symptoms diminished.Then at an unknown time during dialysis therapy, an engineer noted an external fluid leak around the machine.The patient was weighed, and it was noted the results were ¿not meeting expectations¿.The machine was swapped, and therapy was completed without further incident.No further information was available at the time of this report.

Manufacturer Narrative

H10: the device was not received for evaluation; however, the device was evaluated on site by a non-baxter technician.The technician performed a visual inspection and found the ultrafilter leaking.The technician did not report any further evaluation of the ultrafilter device.The reported condition was verified.Since no further evaluation information was received, the cause of the condition could not be determined; however, based on previous investigations the most likely cause was due to a crack in the housing nearby the welding zone.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.

Manufacturer Narrative

Correction to b1 and h1.Based on additional information received, the u9000 ultrafilter set 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: ULTRAFILTER HECHINGEN
• 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: 18280313
• MDR Text Key: 329889482
• Report Number: 9611369-2023-00261
• Device Sequence Number: 1
• Product Code: KDI
• 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,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 114604
• Device Lot Number: 2-1805-H-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 12/19/2023; Not provided
• Supplement Dates FDA Received: 01/11/2024; 02/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/08/2022
• 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 HEMODIALYSIS MACHINE
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male