• 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; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

  • 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; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE Back to Search Results
Device Problems Contamination (1120); Improper or Incorrect Procedure or Method (2017)
Patient Problem Peritonitis (2252)
Event Date 06/15/2014
Event Type  Injury  
Event Description
It was reported that a patient had a break in aseptic technique during peritoneal dialysis (pd) which caused peritonitis.The break in aseptic technique was further described as patient made a mistake/touch contamination.The patient was not hospitalized for the peritonitis event.Treatment for the peritonitis event was not reported.It was not reported if the patient was retrained on proper aseptic technique.It was reported that the patient was recovered from the peritonitis event.Dianeal therapies were ongoing.Additional information was requested but is not available.
 
Manufacturer Narrative
(b)(4).This is a report of a patient who experienced a break in aseptic technique resulting in peritonitis.Per baxter labeling, users are instructed to use aseptic technique when performing peritoneal dialysis therapy.The device was not returned; therefore, a device analysis could not be completed.A review of the label for the product family will be conducted.Should additional relevant information become available, a supplemental report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
Manufacturer (Section G)
BAXTER HEALTHCARE CORPORATION
Manufacturer Contact
christina arnt
25212 w. illinois route 120
round lake, IL 60073
2242703198
MDR Report Key3955241
MDR Text Key16777418
Report Number1416980-2014-24069
Device Sequence Number1
Product Code KDJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/30/2014
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? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/30/2014
Initial Date FDA Received07/24/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
DIANEAL 1.5% AND 2.5% LOW CALCIUM PD4
Patient Age70 YR
-
-