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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO DIALYSATOREN GMBH REVACLEAR 400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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GAMBRO DIALYSATOREN GMBH REVACLEAR 400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number REVACLEAR 400
Device Problem Leak/Splash (1354)
Patient Problem Hemolysis (1886)
Event Date 01/17/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
A patient in (b)(6) was undergoing a dialysis treatment which included a revaclear 400 dialyzer. During treatment, the machine alarmed "blood leak detected" and there was pink colored fluid at the drain that tested positive for blood. Treatment was stopped and the blood in the extracorporeal circuit was not returned to the patient resulting in an undisclosed blood loss. The patient was not symptomatic as a result of the blood loss and required no medical intervention. According to the head nurse, lab test were performed that confirmed a mild degree of hemolysis. Other than an h/h, and liver enzymes the specific tests and values were not provided. The patient was reportedly discharged home the following day.
 
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Brand NameREVACLEAR 400
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO DIALYSATOREN GMBH
holger-crafoord-str. 26
hechingen 72379
GM 72379
Manufacturer (Section G)
GAMBRO DIALYSATOREN GMBH
holger-crafoord-str. 26
hechingen
GM
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2249487578
MDR Report Key6299045
MDR Text Key66427308
Report Number9611369-2017-00019
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K130039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial
Report Date 02/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2019
Device Model NumberREVACLEAR 400
Device Catalogue Number114746
Device Lot Number6-7080-H-01
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 Received01/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/24/2016
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: 02/02/2017 Patient Sequence Number: 1
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