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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 Problems Contamination (1120); Improper or Incorrect Procedure or Method (2017)
Patient Problem Peritonitis (2252)
Event Date 09/21/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).As the sample was not returned and the lot number is unknown, a device analysis cannot be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a patient experienced peritonitis coincident with peritoneal dialysis(pd) therapy.The cause of the peritonitis was reported as the area was not clean prior to starting pd therapy; however, no specific use error was reported, therefore, the cause of the event was assessed as unknown.On the same day as the event onset, the patient was hospitalized for peritonitis.Also that same day, the patient started treatment with intraperitoneal cefazoline 1 gram (frequency and duration not reported) and intraperitoneal ceftazidime1 gram (frequency and duration not reported) for peritonitis.Action taken with dianeal therapy was not reported.The outcome of the event 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 Key5150867
MDR Text Key28295634
Report Number1416980-2015-38979
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
Report Date 10/14/2015
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/14/2015
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 1.5% ULTRABAG
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age60 YR
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