MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION AK 96 MACHINES; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 110655

Device Problem Inadequate Ultra Filtration (1656)

Patient Problems Hypovolemic Shock (1917); Vomiting (2144); Syncope/Fainting (4411)

Event Date 09/14/2022

Event Type  Injury  

Event Description

It was reported that approximately one (1) hour after starting hemodialysis (hd) therapy using an ak 96 control unit, the patient experienced fainting, vomiting and shock.The patient weight was 51.1 kg g after (one) 1 hour of treatment indicating an excessive fluid removal of 4.8l from the start weight.The patient was treated with oxygen administration, 2000 ml normal saline, 5 mg dexamethasone, 20 mg of glucose.The patient recovered from the event.No alarm was generated during the treatment.No additional information is available.

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The actual device was evaluated on site by a local hospital engineer.During inspection a loosened tubing that connect the machine to the dialyzer filter that caused the external leak was found.This was repaired and after reconnecting the loosen connector, the machine was back to normal.The cause of the condition could not be determined.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: AK 96 MACHINES
• 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 - LUND MONITORS; magistratsvagen 16; lund skane lan SE-22 643; SW SE-22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15549983
• MDR Text Key: 301242926
• Report Number: 9616026-2022-00099
• 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
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 110655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: POLYFLUX 14L DIALYZER; SANXIN A- CONCENTRATE; SANXIN BLOOD LINES
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male