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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 Problem Contamination (1120)
Patient Problems Abdominal Pain (1685); Peritonitis (2252)
Event Date 05/26/2014
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 the patient did not clean the exchange area before starting pd therapy.The peritonitis was manifested by abdominal pain.The same day, the patient was hospitalized and began treatment with vancomycin (1 gram once every 4 days, route unreported) for the peritonitis event.Three days after admission to the hospital, the patient was discharged.Eighteen days after the onset of peritonitis, vancomycin was discontinued and the patient was recovered from the event.On an unreported date, the patient was retrained on aseptic technique.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.
 
Manufacturer Narrative
(b)(4).It was reported that the break in aseptic technique included an unspecified touch contamination and also the patient did not wear a mask while performing peritoneal dialysis (pd) therapy.The reporter further stated that the patient was ¿ too relaxed with sanitary precautions which led to peritonitis¿ (not further specified).The patient was hospitalized for the peritonitis on the same day as the updated occurrence date and was discharged four days later.Twenty two days after onset (previously reported as eighteen days after onset) the peritonitis was resolved and the patient was recovered from the event.Should additional relevant information become available, a follow-up will be submitted.
 
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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 Key3930030
MDR Text Key4598590
Report Number1416980-2014-22379
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,Followup
Report Date 06/17/2014
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 07/16/2014
Initial Date FDA Received07/11/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/08/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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% AMBUFLEX; DIANEAL PD4 2.5% AND 4.25% DIANEAL 2.5% ULTRABAG
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age41 YR
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