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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - OPELIKA REVACLEAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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BAXTER HEALTHCARE - OPELIKA REVACLEAR 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 Problem Urticaria (2278)
Event Type  Injury  
Manufacturer Narrative
Date of event: it was reported the event began and occurred on unknown dates then reoccurred on an unknown date in (b)(6) 2019 and (b)(6) 2019. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during an unspecified quantity of patient treatments with unknown revaclear dialyzers, the patient experienced ¿formation of hives¿. It was reported the events occurred during patient treatment. The patient was not hospitalized for the events. It was reported the patient ¿took benadryl on their own¿ when the hives were ¿all over the body¿ and resulted in ¿full recovery from each event¿. It was reported the patient ¿only experiences new hives with each (new) dialysis treatment¿. It was reported on unknown dates; the patient was given oral benadryl 50 mg for the events. It was reported for the last event; the dialyzer was flushed with 2500 ml 0. 9% sodium chloride and the patient was given oral benadryl 50mg before starting treatment and halfway through treatment. Subsequently, the patient experienced hives all over the body during the last hour of treatment. The nurse reported no other treatment or medical interventions were associated with the events. No additional information is available.
 
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Brand NameREVACLEAR
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - OPELIKA
opelika AL
Manufacturer (Section G)
BAXTER HEALTHCARE - OPELIKA
1101 jeter ave
opelika AL 36801
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key8761041
MDR Text Key150030948
Report Number3006552611-2019-00070
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2019
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2019
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

Patient Treatment Data
Date Received: 07/03/2019 Patient Sequence Number: 1
Treatment
EXELTRA; FRESENIUS OPTIFLUX; REVACLEAR 300/400; REVACLEAR MAX
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