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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION AK 96 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 110655
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Cramp(s) /Muscle Spasm(s) (4521)
Event Date 09/24/2021
Event Type  Injury  
Event Description
It was reported that during treatment with an ak96, the machine had occasional transmembrane pressure alarms and the machine spontaneously returned to normal and the treatment was not interrupted. The treatment time was set to four (04) hours and the ultrafiltration (uf) volume was set to 4. 6 l to reach a target weight of (b)(6). After two (02) hours of treatment the patient presented with hypotension (bp 109/78 mmhg) and muscle spasm. The accumulated ultrafiltration volume displayed by the ak 96 was around 2. 0 l and no alarm was generated. The treatment was interrupted and the extracorporeal blood was returned to the patient in addition to infusing 300 ml of saline. The post treatment weight was (b)(6) suggesting that the patient had lost a net weight of 3. 3 kg in two hours whereas the weight loss should have been about 2. 3l. The treatment was interruption and medical intervention with 300 ml saline was administered. The patient's blood pressure returned to normal after rest. No additional information is available.
 
Manufacturer Narrative
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameAK 96
Type of DeviceDIALYZER, 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 Key12700372
MDR Text Key283966588
Report Number9616026-2021-00060
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeCH
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number110655
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 10/26/2021 Patient Sequence Number: 1
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