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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2022

Event Type  malfunction  

Manufacturer Narrative

The reported product is an unknown ultrafilter (hechingen dialyzer).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that after one hour and thirty-four minutes of treatment with an unknown ultrafilter and an ak 98 device, the patient¿s blood pressure (bp) dropped to 99/67 mmhg and the venous pressure was observed to be high (no values provided).Initially, the ultrafiltration (uf) volume was set to 1.6l.After the event, the uf volume was reduced, and 2500 ie heparin was administered.Approximately, 20 minutes later, the patient experienced palpitations, chest tightness, and general discomfort.The bp was 101/71mmhg.Treatment was discontinued and the extracorporeal (ec) blood was returned to the patient.The patient lost 2.7kg in two hours of treatment.There was no report of any additional medical intervention provided no additional information is available.

Manufacturer Narrative

Additional information: b6, b7, d10, h3, h6, h10 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.

• Brand Name: NI
• 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: 14488570
• MDR Text Key: 292511577
• Report Number: 9611369-2022-00088
• 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
• Report Date: 06/09/2022

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2022
• 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 18UC
• Patient Age: 49 YR
• Patient Sex: Male