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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 Contamination (1120)
Patient Problem Peritonitis (2252)
Event Date 02/06/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).The sample was not returned for evaluation and the lot number is unknown, therefore a device analysis could not be performed.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported a patient experienced peritonitis coincident with peritoneal dialysis (pd) therapy.The cause of the peritonitis was unknown.The patient was hospitalized for the event the same day as onset.On an unreported date, the patient began treatment with intraperitoneal magnex injection, 1 gram per day for one bag (duration not reported) for peritonitis.At the time of this report the patient outcome of this peritonitis event was not reported.The action taken with the dianeal therapy was not reported.No additional information is available.
 
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Type of Device
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
Manufacturer (Section G)
BAXTER HEALTHCARE CORPORATION
Manufacturer Contact
kinga almasan
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key5476842
MDR Text Key39570614
Report Number1416980-2016-04485
Device Sequence Number1
Product Code KDJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 03/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2016
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
Date Manufacturer Received02/08/2016
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 PD2 2.5% SOLUTION
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age60 YR
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