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 2020-03-27 for SYSTEM, PERITONEAL, AUTOMATIC DELIVERY manufactured by Baxter Healthcare Corporation.

Event Text Entries

[185478536] An alarm indicative of a potential malfunction of the disposable cassette was reported. The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. However, a loose connection was reported between the supply line of the homechoice cassette and the supply bag, which is known to cause this alarm. The cause of the loose connection could not be determined. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[185478537] It was reported that a homechoice device experienced a system error 2240 (air in line/set) alarm. The patient was connected at the time of the alarm. This occurred during dwell three of five of peritoneal dialysis therapy. During the troubleshooting, it was reported that there was a loose connection between the supply line of the homechoice cassette and the supply bag that led to this alarm. The patient stated that the connection was properly tightened before the therapy started. Renal therapy services (rts) discussed proper procedures per the user manual with the patient. The patient would complete therapy through manual exchange. 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 Number1416980-2020-01805
MDR Report Key9891816
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-03-03
Date Mfgr Received2020-03-03
Date Added to Maude2020-03-27
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 Received2020-03-27
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 2020-03-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.