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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 Problem Peritonitis (2252)
Event Date 07/08/2020
Event Type  Injury  
Manufacturer Narrative
The cause of this peritonitis was use error reported to be due to a break in aseptic technique. 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 patient experienced a breach in aseptic technique that resulted in peritonitis. The breach was further specified as the patient made a mistake (not specified). On the same day as the event onset, the patient was hospitalized for the event. On an unreported date, the patient was treated with amikacin and ceftazidime injections (doses, routes, frequencies and durations were not reported) for peritonitis. Antibiotic treatment was ongoing. The patient has recovered from the peritonitis event and was retrained on 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 60073
2242702068
MDR Report Key10468718
MDR Text Key204862451
Report Number1416980-2020-05278
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeIN
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2020
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/28/2020 Patient Sequence Number: 1
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