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

Device Problem Inadequate Ultra Filtration (1656)

Patient Problems Low Blood Pressure/ Hypotension (1914); Vertigo (2134); Hot Flashes/Flushes (2153); Loss of consciousness (2418); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 04/15/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that after one hour and 45 minutes of treatment using an ak 98 machine with the ultrafiltration (uf) volume set to 0.7l, the patient experienced sweating, dizziness, cramps in both lower extremities and the blood pressure reading was 89/46 mmhg.The patient lost 2.2kg in about two hours of treatment (1.5l more than the set uf volume).The patient was treated with an intravenous infusion of high concentration of glucose, normal saline and oxygen was administered.The patient briefly improved, however, subsequently lost consciousness.Treatment was terminated, the extracorporeal blood was returned to the patient and their clinical condition gradually improved.The patient was advised to ¿drink proper water after returning home, and pay attention to blood pressure, internal fistula tremor, and other discomfort¿.No additional information is available.

Manufacturer Narrative

Correction: a3 additional information: b5, b6, d10, h3, h6, h10 b5: approximately 500 ml of glucose and saline were administered to patient.H10: the device was evaluated on site and repaired by a hospital technician.Visual inspection observed a fluid leak from the u9000.The ultrafilter was changed as the interface of the bacterial filter bracket leaked.The most probable cause was due to the filter not being properly installed.The filter was replaced and the machine run normally.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

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

• Brand Name: ULTRAFILTERS 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 ; 2242702068
• MDR Report Key: 14490720
• MDR Text Key: 292577791
• Report Number: 9611369-2022-00089
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: AK 98 MACHINE; DIALYZER 15UC
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female