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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 Problems Swelling (2091); Reaction (2414)
Event Date 10/02/2018
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
A hemodialysis (hd) patient experienced a swollen tongue.It was reported the patient received hd therapy with an unspecified revaclear dialyzer at an outpatient clinic and at the hospital.It was unknown when the patient received their last hd treatment with the revaclear dialyzer.It was reported the patient presented to the emergency room and was admitted with ¿tongue swelling¿.Thirty minutes later, the swelling worsened, the patient was unable to breathe and was subsequently intubated.The following day the patient received inpatient hd therapy.It was reported the patient was in the intensive care unit for ¿approximately 7 or 8 days¿.Further treatment was not reported.At the time of this report, the patient outcome was not reported; however, it was reported the patient was ¿no longer in the hospital¿.No additional information is available.
 
Manufacturer Narrative
The device was not returned and no batch review could be performed as no lot number was made available.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
REVACLEAR
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - OPELIKA
opelika AL
MDR Report Key8042170
MDR Text Key126271035
Report Number3006552611-2018-00019
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K072232
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/05/2018,11/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/05/2018
Distributor Facility Aware Date10/11/2018
Event Location Outpatient Treatment Facility
Date Report to Manufacturer11/05/2018
Date Manufacturer Received11/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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