SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-31 for SYSTEM, PERITONEAL, AUTOMATIC DELIVERY manufactured by Baxter Healthcare Corporation.

Event Text Entries

[185900790] 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


[185900791] It was reported that a patient experienced air in the patient line of the homechoice cassette. This occurred during initial drain of automated peritoneal dialysis therapy. The home patient (hp) was connected at the time of the event. There was nothing unusual found during troubleshooting with renal therapy services (rts) that would cause or contribute to the event. The hp would start over using new supplies. Rts discussed continuous ambulatory peritoneal dialysis and reviewed proper procedures per the user manual. There was no patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1416980-2020-01887
MDR Report Key9908374
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-06
Date Mfgr Received2020-03-06
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 - MOUNTAIN HOME
Manufacturer Street1900 N HIGHWAY 201
Manufacturer CityMOUNTAIN HOME AR 72653
Manufacturer CountryUS
Manufacturer Postal Code72653
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNI
Generic NameSYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Product CodeFKX
Date Received2020-03-31
Model NumberNA
Catalog NumberASKU
Lot NumberASKU
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
10 2020-03-31

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