MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 050-87216

Device Problem Fluid/Blood Leak (1250)

Patient Problem Uremia (2188)

Event Date 08/26/2018

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A peritoneal dialysis nurse (pdrn) reported a patient who was hospitalized on (b)(6) 2018 due to uremia caused by missed peritoneal dialysis treatments.Additional information was requested, but was not provided.

Manufacturer Narrative

Report source section 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.

Manufacturer Narrative

It was reported this patient on peritoneal dialysis (ccpd) was hospitalized on (b)(6) 2018 due to uremia.Approximately 5 days prior to the hospitalization, on (b)(6) 2018, the patient reported ¿m31 air detected in cassette¿ alarm during pd treatment (unknown phase) with a reported observable fluid leak coming from the cassette door of the liberty select cycler.The patient reported he ended pd treatment on (b)(6) 2018 and was going to revert to manual pd therapy and the liberty select cycler was processed for replacement.According to the patient¿s pd nurse, the cause of the patient¿s uremia was related to missed pd treatments as the patient became frustrated with the fluid leak with the liberty select cycler and reportedly did not performing manual pd treatments correctly.The nurse stated the patient continued pd therapy (unknown products) while hospitalized.No further information surrounding the patient¿s hospitalization course, including patient disposition, are known despite multiple due diligence attempts.Based on the available information, the patient¿s uremia which resulted in hospitalization is most likely associated with missed/inadequate pd treatment.The patient reportedly was not adequately performing manual pd treatments (back up pd method) after experiencing a ¿m31 air detected in cassette¿ alarm and reported fluid leak approximately 5 days prior to hospitalization which led to replacement of the liberty select cycler.At this time, a possible contributory relationship between the liberty select cycler/liberty cycler set and the patient¿s uremic event cannot be excluded; however, there is no documentation which indicates the liberty select cycler/liberty cycler set malfunctioned.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• 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: 7850296
• MDR Text Key: 119342957
• Report Number: 8030665-2018-01363
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 050-87216
• Device Lot Number: 18ER08075
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/06/2018
• Supplement Dates Manufacturer Received: 09/19/2018; 10/09/2018
• Supplement Dates FDA Received: 09/24/2018; 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization