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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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BAXTER HEALTHCARE CORPORATION; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Peritonitis (2252)
Event Date 06/24/2014
Event Type  Injury  
Event Description
It was reported that a patient experienced bacterial peritonitis coincident with peritoneal dialysis (pd) therapy.The cause of the peritonitis was unknown.The patient was hospitalized on the same day as onset of the peritonitis.The patient was treated with cefacidal and fortum intraperitoneally for 4 days, and orbenine orally (dose and frequency not reported) for the event.Nine days after hospitalization, the patient was discharged and was reported to be recovered from the peritonitis event.One day after discharge, the patient was treated with vancomycin (1 gram intraperitoneally, frequency not reported).Vancomycin dose was repeated three days after the onset of vancomycin therapy.It was reported that twenty seven days after discharge, the patient was hospitalized for cloudy effluent.The cause of the cloudy effluent was unknown.The patient was diagnosed with aseptic peritonitis.The patient was treated with cefacidal and fortum (doses, frequencies and routes not reported) for the sterile peritonitis.Nineteen days after the onset of the sterile peritonitis, the patient was diagnosed with recurrent sterile peritonitis manifested by cloudy effluent and inflammatory syndrome.The patient was not hospitalized for the recurrent event.At the time of this report, the patient was not recovered from the peritonitis event.Additional information was requested but is not available.Physioneal therapy was ongoing.This is report 4 of 4 involved in this event.
 
Manufacturer Narrative
(b)(4).The reported product is an unknown baxter cassette.Should additional relevant information become available, a supplemental report will be submitted.This report involves the same patient as in (b)(4).
 
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Type of Device
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
Manufacturer (Section G)
BAXTER HEALTHCARE CORPORATION
Manufacturer Contact
christina arnt
25212 w. illinois route 120
round lake, IL 60073
2242703198
MDR Report Key4141263
MDR Text Key4797241
Report Number1416980-2014-34477
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/08/2014
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 09/08/2014
Initial Date FDA Received10/03/2014
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
HOMECHOICE, MINICAP, TRANSFER SET; TITANIUM ADAPTER, 1.36% PHYSIONEAL 35,
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age82 YR
Patient Weight70
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