• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION REVACLEAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAXTER HEALTHCARE CORPORATION REVACLEAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 114745L
Device Problem Fluid/Blood Leak (1250)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/17/2023
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported two (2) internal blood leaks were observed in a revaclear 300.Forty minutes into hemodialysis therapy, the unspecified hemodialysis machine alarmed internal blood leak.The patient lost 250ml of blood.The patient was restarted on a new machine and new revaclear (from the same lot).Again 40 minutes into therapy, the machine alarmed internal blood leak.The patient lost another 250ml of blood.The patient was set up with a new machine and a revaclear from a different lot number.Therapy was completed with no issues.The following day, the patient underwent a blood transfusion.No additional information is available.
 
Manufacturer Narrative
Additional information: h6 and h10.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
REVACLEAR
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
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 Key16755799
MDR Text Key313449634
Report Number3006552611-2023-00013
Device Sequence Number1
Product Code KDI
UDI-Device Identifier07332414123055
UDI-Public(01)07332414123055
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 Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 06/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number114745L
Device Lot NumberC623300107
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/20/2023
Initial Date FDA Received04/17/2023
Supplement Dates Manufacturer Received05/19/2023
Supplement Dates FDA Received06/14/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
UNSPECIFIED HEMODIALYSIS MACHINE.
Patient Outcome(s) Required Intervention;
-
-