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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 09/02/2015
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.It was reported the patient was not hospitalized for the event.On an unreported date, the patient began treatment with reflin injection 1 gram, once daily (route and duration not reported) and intraperitoneal fortum injection 1 gram in one bag each (duration not reported) for peritonitis.At the time of this report the patient outcome of this peritonitis event was unknown.Dianeal therapy was ongoing.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 Key5091378
MDR Text Key26309965
Report Number1416980-2015-36703
Device Sequence Number1
Product Code KDJ
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Report Date 09/21/2015
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/21/2015
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 PD4 1.5% ULTRABAG SOLUTION
Patient Outcome(s) Required Intervention;
Patient Age65 YR
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