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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER THERANOVA 400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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.
 
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Brand NameTHERANOVA 400
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER
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 60073
2242702068
MDR Report Key10148544
MDR Text Key199893444
Report Number9611369-2020-00069
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number115578
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/12/2020 Patient Sequence Number: 1
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