MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, DUAL PATIENT CONNECT; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 050-87212

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

Patient Problems Abdominal Pain (1685); Fever (1858); Peritonitis (2252)

Event Date 04/06/2019

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler/liberty cycler set and the adverse event(s) of abdominal pain, cloudy effluent and fever which warranted hospitalization and initiation of antibiotic treatment.Based on the information available, the cause of the patient's streptococcus mitis peritonitis is unknown.However, there is no allegation nor any objective evidence indicating the patient¿s liberty select cycler and/or liberty cycler set caused or contributed to the patient's event of peritonitis.Peritonitis is a well-known potential complication in patients utilizing pd therapy.Streptococcus mitis is a known colonizer of the human oropharynx and gastrointestinal tract.The entry pathway of this bacterium into the peritoneal cavity can include contamination during the exchange procedure, gastrointestinal bacterial translocation, and hematological dissemination with oral and dental procedures as well as catheter contamination.

Event Description

On (b)(6) 2019, this (b)(6) female patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis (ccpd) for renal replacement therapy (rrt) was reported to have developed peritonitis.There were no reported liberty select cycler/liberty cycler set product(s) issues or malfunctions reported during this initial call.Upon follow-up, the peritoneal dialysis registered nurse (pdrn) reported the patient was hospitalized on (b)(6) 2019 for abdominal pain, cloudy pd effluent, and fever.A sample of pd effluent was obtained for culture and cell count and the patient was prophylactically treated for suspected peritonitis with intraperitoneal (ip) vancomycin (1.9 gram), and ceftazidime (1.9 g gram) times one dose.The pdrn also reported, the patient was discharged to their home on (b)(6) 2019.The pdrn stated on (b)(6) 2019, the patient¿s pd effluent cultures yielded growth of streptococcus mitis, confirming a diagnosis of peritonitis.Cell count was not available.Per the pdrn, the patient was started on and is currently completing a 28-day course of vancomycin, 0.5 gram via ip dwell every 4 days.The pdrn also reported the cause of peritonitis is unknown.Additionally, the pdrn states the patient denied experiencing any fluid leaks liberty select cycler/liberty cycler set product issues or malfunctions related to this event; and the patient is recovering and continues pd treatment without further reported issues.

Manufacturer Narrative

Correction: outcomes attributed to adverse event: - removed life threatening.Patient codes.

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: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• 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: 8551663
• MDR Text Key: 143223008
• Report Number: 8030665-2019-00638
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100736
• UDI-Public: 00840861100736
• 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: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87212
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 04/29/2019
• 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; Life Threatening; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 93