MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER THERANOVA 400; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 115578

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Airway Obstruction (1699); Seizures (2063); Lethargy (2560)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

The patient's age was described as "young age".Initial reporter facility name: (b)(6) hospital - children kidney center.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that two days after the patient started using theranova 400 dialyzer, the patient started to experience breakout seizures up to three times a day.Three days later, the patient's dosage of valproate was increased (dosage not further specified) and the patient was admitted to the hospital to control the seizures.Intravenous (iv) administration of phenobarbitone was prescribed during and after dialysis but the frequency of partial seizures without neurological recovery increased and the patient was observed to have become drowsy with facial asymmetry.Five days after switching to the theranova 400 dialyzer, the patient was described as having "onset of increased tone of l ul and ll posture".Clobazam was switched to iv administration of midazolam, valporate was switched to iv administration and the dosage was increased, and phenobarbitone dosage was decreased.It was reported that midway into treatment and following completion of this treatment, the patient presented with continuous seizures for two hours (status epilepticus) necessitating hospital admission due to persistent drowsiness, low glasgow coma scale score, airway obstruction and low saturation.Medical intervention involved invasive ventilation for respiratory depression secondary to postictal encephalopathy, blood flow rate 300 ml/min, dialysis fluid flow rate 700 ml/min, treatment time 4h and the ultrafiltration rate was set to 0.3l/h.Dialysis sodium concentration was 138 mmol/l and bicarbonate 34 mmol/l.Further adjustment of the medications were made six and seven days after stating treatment with theranova 400 dialyzer, but the treatments were associated with two intra dialysis seizures.At this point, it was decided to switch the patient back to the polyflux dialyzer.No further seizures were observed after the switch back to polyflux.No additional information is available.

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: THERANOVA 400
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; deerfield IL
• MDR Report Key: 10148544
• MDR Text Key: 199893444
• Report Number: 9611369-2020-00069
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 115578
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/20/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 06/22/2020
• Supplement Dates FDA Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 75