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

Catalog Number 114362

Device Problem Inadequate Ultra Filtration (1656)

Patient Problems Low Blood Pressure/ Hypotension (1914); Nausea (1970); Twitching (2172); Dizziness (2194); Discomfort (2330); Gastrointestinal Regurgitation (4477)

Event Date 03/21/2023

Event Type  Injury  

Manufacturer Narrative

E1: initial reporter address: (b)(6).H10: the device was not received for evaluation; however, the device was evaluated on site by a non-baxter technician.The technician reported a total deviation of 3l occurred; however, the treatment time was not reported, in order to calculate the deviation per hour.The reported issue was not duplicated through a treatment simulation, because the technician reports the uf cell failed the calibration.The technician did replace the uf module.The reported condition was verified.The cause of the condition could not be determined; however, the most probable cause was a defective uf module.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.

Event Description

It was reported an excessive ultrafiltration event occurred on an ak 96 machine which the patient subsequently experienced hypotension.During hemodialysis, the patient ¿complained of twitching discomfort in the lower limbs.The nurse immediately measured the blood pressure at 105/66mmhg and suspended the ultrafiltration as directed by the doctor¿.Fifteen minutes later, the blood pressure was re-measured and was ¿108/68 mmhg¿.The patient complained ¿the lower extremity convulsions were better than before and continued to suspend the ultrafiltration treatment¿.Thirty-one minutes later, the patient complained of ¿dizziness, nausea and discomfort, and vomited a small amount of gastric contents¿.The patient¿s blood pressure was immediately taken and was ¿59/42 mmhg¿.This was reported to the doctor who ordered to adjust the body position.The patient ¿went to the supine position to rest¿.The patient was reinfused 100ml of 0.9% normal saline and got off the machine.Four minutes later, the blood pressure was retested, and it was ¿99/66mmhg¿.The patient stated, ¿the dizziness and nausea were better than before¿.After getting off the machine, the machine displayed an ultrafiltration volume of 1350ml.The patient weighed 54kg after dialysis, and the actual weight decreased by 3kg compared with before dialysis.There was a large deviation between the setting and the actual ultrafiltration, and the machine dehydrated more.The patient had no dizziness or discomfort at this point.

• 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 60073 ; 2242702068
• MDR Report Key: 17835614
• MDR Text Key: 324498756
• Report Number: 9616026-2023-00076
• 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
• Report Date: 09/28/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 114362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/28/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 57 KG