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

Model Number LIBERTY CYCLER SET,

Device Problem Device Contamination with Body Fluid (2317)

Patient Problems Peritonitis (2252); Palpitations (2467)

Event Date 06/23/2018

Event Type  Injury  

Manufacturer Narrative

Clinical review: a temporal relationship exists between the fluid leak which occurred on (b)(6) 2018 during ccpd therapy with the liberty select cycler/liberty cycler set and the pt¿s subsequent hospitalization on (b)(6) 2018 for peritonitis characterized by abdominal pain.Due to the risk of contamination with the reported fluid leak; a possible causal/ contributory association cannot be ruled out.However, it is unknown what may have caused the fluid leak to occur.Plant investigation: a supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

During routine follow up on an unrelated customer experience, a peritoneal dialysis patient contact reported that the patient was hospitalized on (b)(6) 2018 for abdominal pain and possible peritonitis.Follow up with the patient¿s peritoneal dialysis nurse indicated that the patient was presented to the hospital with abdominal pain and peritonitis.The patient¿s pd effluent was significantly cloudy and culture grew pseudomonas and escherichia coli.The patient was treated with intravenous (iv) merrem until (b)(6) 2018 (unknown strength and frequency).Per the patient¿s peritoneal dialysis nurse the patient continued pd therapy while hospitalized.However, it was recorded in the discharge summary received the patient required removal of his pd catheter (not a fresenius product) on an unknown date during hospitalization and the patient was not continued with renal replacement therapy.

Manufacturer Narrative

Lot number plant investigation: a supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

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Manufacturer Narrative

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.

Event Description

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• 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: 7688682
• MDR Text Key: 114009183
• Report Number: 8030665-2018-01042
• 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: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Model Number: LIBERTY CYCLER SET,
• Device Catalogue Number: 050-87216
• Device Lot Number: 18BR08148
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: MO
• Date Manufacturer Received: 07/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY SELECT CYCLER; PD SOLUTION
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR