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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Distention (2601); Swelling/ Edema (4577)
Event Date 07/06/2021
Event Type  Injury  
Event Description
It was reported that during treatment with an ak 96 machine, a transmembrane pressure (tmp) alarm was generated as the tmp was negative at 65 mmhg, indicating backfiltration was likely occurring. The dialysis system was checked and the tmp alarm limits were adjusted. The tmp decreased to -35 mmhg. It was reported this event occurred several times. Twenty-four (24) minutes later the patient complained of abdominal distension and facial edema was observed. The treatment was interrupted and the post treatment weight was reported to be 64kg. Indicating that the patient had gained 11 kg during the elapsed treatment time. The patient was treated with isolated ultrafiltration during which 6000ml fluid was removed. The blood pressure was recorded as 103/77 mmhg at completion of the treatment. And the patient recovered. No additional information is available.
 
Manufacturer Narrative
Facility name: (b)(6) medical university. Phone number: (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 Key12898208
MDR Text Key283517454
Report Number9616026-2021-00070
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
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 12/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/28/2021
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: 11/30/2021 Patient Sequence Number: 1
Treatment
FISTULA NEEDLE 16G 25 MM
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