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 050-87216

Device Problem Use of Device Problem (1670)

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

Event Date 10/07/2022

Event Type  Injury  

Manufacturer Narrative

Clinical review: the file was assessed to determine whether a clinical investigation is warranted.On (b)(6) 2022, fresenius became aware this 39-year-old female patient with end stage renal disease (esrd) previously on continuous cyclic peritoneal dialysis [cc(pd)] 7 days-a-week for renal replacement therapy (rrt) was diagnosed with peritonitis.No additional information provided during intake.Follow-up with the patient¿s primary pd registered nurse (pdrn) revealed the patient presented to the outpatient home dialysis unit on (b)(6) 2022 with complaints of abdominal pain and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (wbc¿s >5000, polymorphs = 90%) were collected, and the patient was diagnosed with peritonitis.The patient was treated with intraperitoneal (ip) vancomycin 2000 mg every four days and ceftazidime 2000 mg daily.The patient¿s peritoneal effluent culture result returned negative on (b)(6) 2022, and the patient¿s antibiotics were continued.The pdrn attributed causality to the patient¿s ¿blue pin¿ falling out of the liberty cycler set onto the ground, after which the patient reinserted the blue pin and completed pd therapy.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A nurse reported a patient with end stage renal disease (esrd) previously on continuous cyclic peritoneal dialysis [cc(pd)] 7 days-a-week for renal replacement therapy (rrt) was diagnosed with peritonitis.In a follow-up with the patient¿s primary pd registered nurse (pdrn) revealed the patient presented to the outpatient home dialysis unit on (b)(6) 2022 with complaints of abdominal pain and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (wbc¿s >5000, polymorphs = 90%) were collected, and the patient was diagnosed with peritonitis.The patient was treated with intraperitoneal (ip) vancomycin 2000 mg every four days and ceftazidime 2000 mg daily.The patient¿s peritoneal effluent culture result returned negative on (b)(6) 2022, and the patient¿s antibiotics were continued.The pdrn attributed causality to the patient¿s ¿blue pin¿ falling out of the liberty cycler set onto the ground, after which the patient reinserted the blue pin and completed pd therapy.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.

Event Description

A nurse reported a patient with end stage renal disease (esrd) previously on continuous cyclic peritoneal dialysis [cc(pd)] 7 days-a-week for renal replacement therapy (rrt) was diagnosed with peritonitis.In a follow-up with the patient¿s primary pd registered nurse (pdrn) revealed the patient presented to the outpatient home dialysis unit on (b)(6) 2022 with complaints of abdominal pain and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (wbc¿s >5000, polymorphs = 90%) were collected, and the patient was diagnosed with peritonitis.The patient was treated with intraperitoneal (ip) vancomycin 2000 mg every four days and ceftazidime 2000 mg daily.The patient¿s peritoneal effluent culture result returned negative on (b)(6) 2022, and the patient¿s antibiotics were continued.The pdrn attributed causality to the patient¿s ¿blue pin¿ falling out of the liberty cycler set onto the ground, after which the patient reinserted the blue pin and completed pd therapy.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.

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-conformances 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.A review of the user guide was performed.The user guide states as a warning before starting the treatment, ¿you must use aseptic technique as directed by your pd nurse to prevent infection¿.At this time, the reported incident could be attributed to end user error in accordance with the complaint description.The alleged event is confirmed since the incident was caused by the user.

• 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
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 1100 e. military hwy, suite c; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 15693539
• MDR Text Key: 302693939
• Report Number: 0008030665-2022-01254
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• Combination Product (y/n): N
• PMA/PMN Number: K173718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 050-87216
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 96 KG