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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

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BAXTER HEALTHCARE CORPORATION SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Abdominal Pain (1685); Peritonitis (2252)
Event Date 07/19/2021
Event Type  Injury  
Manufacturer Narrative
This report is for a breach in aseptic technique which resulted in peritonitis. Per baxter labeling, users are instructed to use aseptic technique when performing peritoneal dialysis therapy. A review of the label for the product family will be conducted. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
A peritoneal dialysis (pd) patient experienced a breach in aseptic technique which resulted in peritonitis manifested by abdominal pain. The breach in aseptic technique was further described as due to contamination. The patient was hospitalized for the event four days after onset. The patient was treated with unspecified antibiotic (intraperitoneum, dose and frequency were not reported). At the time of this report, hospitalization and treatment were ongoing and the patient has not recovered from the event. It was not reported if the patient was retrained on the proper aseptic technique. No additional information is available.
 
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Brand NameNI
Type of DeviceSET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE CORPORATION
ni
ni
ni
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key12338606
MDR Text Key267141281
Report Number1416980-2021-05104
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeRP
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/18/2021 Patient Sequence Number: 1
Treatment
AMPLODIPINE; CYCLER; CYCLER; DIANEAL 1.5%; DIANEAL 2.5%; FERROUS SULFATE; FOLIC ACID; LOSARTAN; RENVELA
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