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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE; 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 06/06/2014
Event Type  Injury  
Event Description
It was reported a patient experienced peritonitis coincident with peritoneal dialysis (pd) therapy.On an unreported date the patient received 2 doses of vancomycin 2000 mg each dose, intraperitoneally.The cause of the peritonitis was a breach in aseptic technique further described as the patient did not wear a mask at the time of therapy.It was reported the patient was not hospitalized for the event.At the time of this report the patient was recovered from this peritonitis event.No additional information is available.
 
Manufacturer Narrative
(b)(4).The cause of this peritonitis was use error.Per baxter labeling, users are instructed to use aseptic technique when performing peritoneal dialysis therapy.A formal review of the label for the product family will be conducted.If additional relevant information is received, a supplemental medwatch will be filed.
 
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Type of Device
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
Manufacturer (Section D)
BAXTER HEALTHCARE
Manufacturer (Section G)
BAXTER HEALTHCARE
Manufacturer Contact
christina arnt
25212 w. illinois route 120
round lake, IL 60073
2242703198
MDR Report Key3930211
MDR Text Key4585287
Report Number1416980-2014-22416
Device Sequence Number1
Product Code KDJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/18/2014
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 06/18/2014
Initial Date FDA Received07/11/2014
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 LOW CALCIUM 2.5% SINGLEBAG
Patient Outcome(s) Required Intervention;
Patient Age78 YR
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