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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION AK 98 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION AK 98 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955603
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Low Blood Pressure/ Hypotension (1914); Skin Discoloration (2074)
Event Date 12/02/2021
Event Type  Injury  
Event Description
It was reported that dialysis treatment with an ak 98 machine was started at 20ml per minute and after the device ¿sensed blood¿ it auto adjusted to 50ml per minute. The patient ¿became blue¿ and the blood pressure dropped (bp) to 40mmhg. The bp prior to start of treatment was not reported. Treatment was discontinued and the patient was administered a bolus of saline (into the atrial line). Treatment was restarted; however, the device began therapy at 100 ml per minute, therefore treatment was discontinued with ¿nil¿ blood loss reported. The patient outcome was not reported. No additional information is available.
 
Manufacturer Narrative
Initial reporter postal code: (b)(6). The device was evaluated on site by a qualified technician. Review of the event history log showed that the blood pump started at 50 ml/min and not at 20 ml/min, as reported. The preset files, provided by the reporter, showed the blood flow at start-up was set at 50ml/min and the blood flow at low limit at startup was equal to 20 ml/min. The machine worked as per specification, according to set value reported in preset files provided for the machine. After treatment was discontinued the blood pump remained stopped until the nurse selected the rinse back option. The blood pump of machine started at 100 ml/min as rinse back flow. Immediately the blood flow was decreased manually from 100 ml/min to 25 ml/min. The technical investigation of the ak 98 machine did not identify any device malfunction. The ak 98 machine worked as per manufacturer specification according to preset values that were reprogrammed and corrected. No machine deviation was identified during the event history log review. The reported condition was not verified. A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event. The cause of the condition is associated with the preset values that were not selected to have default value lower and useful for pediatric treatment. Preset values has to be changed from 50 ml/min to 20 ml/min and preset of rinse back has to be changed from 100 ml/min to 25 ml/min as lower value selectable to have default value lower and useful for pediatric / infant application. As reported in the operator's manual (intended use), the ak 98 hemodialysis machine is indicated to be used on patients with a body weight of 25 kg or more. The ak 98 operator's manual warns the user about: "if treating patients weighing below 25 kg it is recommended that uf supervision alarm limits are configured accordingly by an authorized service technician. " "the treatment of patients with a weight below 25 kg shall be performed under the full supervision of the physician. In these cases, additional measures to supervise the patient weight loss as per standard of care for low body weight is recommended. Failure to do so could result in serious adverse consequences like hypovolemia and hypotension¿. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameAK 98
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - MEDOLLA MODENA MONITORS
via modenese, 66
medolla modena 41036
IT 41036
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key13100177
MDR Text Key288299536
Report Number9616240-2021-00006
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Nurse Practitioner
Type of Report Initial,Followup
Report Date 02/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number955603
Was Device Available for Evaluation? No
Date Manufacturer Received01/21/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/28/2021 Patient Sequence Number: 1
Treatment
BICART CARTRIDGE; PEDIATRIC BLOOD LINES; POLYFLUX DIALYZER; SOFTPAC; TENCKHOFF CATHETER
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