SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE manufactured by Baxter Healthcare Corporation.

Event Text Entries

[185990425] The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[185990426] A peritoneal dialysis (pd) patient experienced relapsed peritonitis which was manifested by cloudy fluid. The cause of the event was not reported. It was not reported if the patient was hospitalized for the event. The patient was treated with gentamycin (dose, route, frequency and duration not reported) for peritonitis. At the time of this report, treatment was completed and the patient has now fully recovered from the event. Action taken with pd therapy was not reported. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1416980-2020-01860
MDR Report Key9908028
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-09
Date Mfgr Received2020-03-09
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone2242702068
Manufacturer G1BAXTER HEALTHCARE CORPORATION
Manufacturer StreetNI NI
Manufacturer CityNI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNI
Generic NameSET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
Product CodeKDJ
Date Received2020-03-31
Model NumberNA
Catalog NumberNI
Lot NumberNI
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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