LIBERTY CYCLER SET, SINGLE CONN./EXT. DL 050-87216

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for LIBERTY CYCLER SET, SINGLE CONN./EXT. DL 050-87216 manufactured by Erika De Reynosa, S.a. De C.v..

Event Text Entries

[185968687] Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed. A batch records review was conducted by the manufacturer for the reported lot. There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event. The entire lot has been sold and distributed. In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements. The lot met all specifications for release. A product history review did not reveal a probable cause for the customer complaint. As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10


[185968688] It was reported that a peritoneal dialysis (pd) patient encountered a fluid leak from within the cycler's cassette compartment during drain 2 of pd treatment. The patient reported receiving air detected in cassette alarms twice during drain 2. The leak began during drain 2 of treatment. The source of the leak is unknown. It was reported that there was fluid within the cycler. The patient was advised to discontinue the use of the cycler and follow up with the peritoneal dialysis nurse (pdrn). A new cycler was issued to the customer. It was reported that an alternate treatment option was available. Upon follow up, the patient reported that treatment was completed with continuous ambulatory peritoneal dialysis (capd). The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event. The patient has received a new cycler which is working well and is continuing peritoneal dialysis therapy with no further issues. The cassette used by the patient was discarded and is not available to return for physical evaluation by the manufacturer. The reported cycler has been returned to the manufacturer for physical evaluation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8030665-2020-00378
MDR Report Key9908838
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-04-01
Date of Event2020-03-19
Date Mfgr Received2020-03-19
Device Manufacturer Date2019-12-12
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 ContactMATTHEW AMARAL
Manufacturer Street920 WINTER ST
Manufacturer CityWALTHAM MA 02451
Manufacturer CountryUS
Manufacturer Postal02451
Manufacturer Phone7816999758
Manufacturer G1ERIKA DE REYNOSA, S.A. DE C.V.
Manufacturer StreetDIRECTOR, QUALITY SYSTEMS 1100 E, MILITARY HWY, SUITE C
Manufacturer CityPHARR TX 78577
Manufacturer CountryUS
Manufacturer Postal Code78577
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLIBERTY CYCLER SET, SINGLE CONN./EXT. DL
Generic NameSYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Product CodeFKX
Date Received2020-03-31
Model Number050-87216
Catalog Number050-87216
Lot Number19SR08025
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeMO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerERIKA DE REYNOSA, S.A. DE C.V.
Manufacturer AddressMIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA REYNOSA 88780 MX 88780


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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