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U.S. Department of Health and Human Services

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

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BAXTER HEATHCARE CORPORATION; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE Back to Search Results
Device Problems Contamination (1120); Improper or Incorrect Procedure or Method (2017)
Patient Problems Bacterial Infection (1735); Fever (1858); Peritonitis (2252)
Event Date 06/16/2014
Event Type  Injury  
Event Description
It was reported that a patient experienced a break in aseptic technique during peritoneal dialysis (pd) therapy which resulted in peritonitis.The break in aseptic technique was further described as touch contamination.The peritonitis was manifested by fever.The same day, the patient was hospitalized for the peritonitis event.The peritonitis event was not medically confirmed.The patient was treated prophylactically with cefazolin intraperitoneally (ip) for 21 days (done not reported) for peritonitis.Two days after admission to the hospital, the patient was discharged.The care giver (cg) was retrained on proper aseptic technique as a precaution.Pd therapy was ongoing.At the time of this report, the patient was recovering from the event and pd therapy was ongoing.Additional information was requested but is not available.
 
Manufacturer Narrative
(b)(4).The cause of this peritonitis was use error reported to be due to a break in aseptic technique by the patient.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 there is any further relevant information from that review, a supplemental medwatch will be filed.
 
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Type of Device
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
Manufacturer (Section D)
BAXTER HEATHCARE CORPORATION
Manufacturer (Section G)
BAXTER HEALTHCARE CORPORATION
Manufacturer Contact
christina arnt
25212 w. illinois route 120
round lake, IL 60073
2242703198
MDR Report Key3932283
MDR Text Key4531936
Report Number1416980-2014-22538
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 06/19/2014
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 06/19/2014
Initial Date FDA Received07/14/2014
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 PD4 2.5% AMBUFLEX AND EXTRANEAL; DIANEAL PD4 2.5% ULTRABAG
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age60 YR
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