MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. FMC CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number UNKNOWN- FMC CASSETTE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: the file was assessed to determine whether a clinical investigation is warranted.On 10/aug/2019, fresenius became aware a patient with renal failure (rf) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy was hospitalized (specifics and dates not provided).Subsequent attempts to obtain additional information have thus far proven unsuccessful.Based on the information available, the liberty select cycler and fmc cassette are disassociated from the event(s), as there is no allegation or objective evidence indicating a product deficiency or malfunction caused or contributed to the patient¿s hospitalization.Therefore, the completion of a clinical investigation is not warranted at this time.Should additional information become available, please re-submit for a clinical review and the need for a clinical investigation will be reassessed accordingly.

Event Description

A hospital nurse called in to report a fluid leak during an unknown patient's peritoneal dialysis (pd) treatment on the liberty select cycler.The fluid leak is captured and investigated in a separate record.Patient information and reason for patient's hospitalization was not reported.Multiple attempts were made to acquire additional information, however, to this date no response has been received.

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius liberty cycler sets shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformance's or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr 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.

• Brand Name: FMC CASSETTE
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 8940382
• MDR Text Key: 160616217
• Report Number: 8030665-2019-01369
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- FMC CASSETTE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Outcome(s): Hospitalization