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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO DIALYSATOREN GMBH REVACLEAR 300 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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GAMBRO DIALYSATOREN GMBH REVACLEAR 300 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 114745
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Vomiting (2144); Loss of consciousness (2418)
Event Date 03/01/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
A hemodialysis (hd) patient has been experiencing multiple allergic reactions of unknown origin at various levels of severity. The patient¿s hd nurse reported that the patient¿s reactions are ¿very random,¿ occurring at various times including prior to hd treatment, during hd treatment, and post hd treatments, including reactions at the patient¿s home and on days the patient did not receive hd treatments. The reactions include the following symptoms at various times and degrees (not further specified): welts/hives/rash all over body, itching, lips and facial swelling, raspy voice, nausea and vomiting, unstable blood pressure or drop in blood pressure, convulsions, and normal saline boluses in the presence of fluid overloaded. In addition, it was reported that the patient will ¿just pass out¿, including one time when the patient fell out of their wheelchair (date unknown). The patient was hospitalized for five days related to the multiple allergic reactions. During treatment, the patient has received micera (occasionally), doxercalciferol, diphenhydramine (intravenously prior to hd treatment), acetaminophen, and midodrine prn. No additional information is available.
 
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Brand NameREVACLEAR 300
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
2242702068
MDR Report Key6565459
MDR Text Key75090569
Report Number9611369-2017-00038
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
Report Date 05/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2019
Device Catalogue Number114745
Device Lot Number6-9305-H-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/12/2017
Distributor Facility Aware Date04/17/2017
Event Location No Information
Date Report to Manufacturer05/12/2017
Date Manufacturer Received04/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/28/2016
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: 05/13/2017 Patient Sequence Number: 1
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