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 Problems Contamination (1120); Use of Device Problem (1670)

Patient Problem Peritonitis (2252)

Event Date 07/08/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, and the lot number was not able to be obtained to date.Distribution records were reviewed to identify potential lots of this product shipped to the customer over the past 3 months.The entire set of lots have been sold and distributed.Batch records for the lots identified were reviewed and confirmed there were no deviations or non-conformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.

Event Description

During follow up on an unrelated event the patient's peritoneal dialysis (pd) nurse reported the patient had been hospitalized for peritonitis.During additional follow up the nurse reported the patient was hospitalized starting on (b)(6) 2017 and discharged (b)(6) 2017.The patient's effluent culture was positive for peritonitis due to pseudomonas.More specific type was not available.The patient's nephrologist prescribed removal of pd catheter and transition to hemodialysis, which patient has done.The patient is expected to return to pd treatment in the future.The antibiotic regimen was unknown.The infection was due to a breach in aseptic technique.The patient's caregiver dropped a part of the patient's line onto the floor and then applied that same part onto the catheter.The patient was hooking up for treatment (b)(6) 2017 at the time and developed symptoms the day after.If / when patient returns to pd there will be retraining on proper technique.The patient's hospital discharge was not available.The set was not made available for evaluation.

Manufacturer Narrative

Clinical review: a clinical investigation was performed to identify a causal relationship between the patient's peritoneal dialysis (pd) treatment and the event of peritonitis.There is a probable associate between the reported peritonitis and a breach in aspect technique at home during pd therapy.In is unclear if the patient was using fresenius products during hospitalization.There is no allegation against any fresenius product related to the adverse event.Should additional new information be made available this clinical investigation will be reevaluated.

Event Description

".".

• 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.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6775059
• MDR Text Key: 82085071
• Report Number: 8030665-2017-00547
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 09/21/2017
• 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; LIBERTY CYCLER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 27 YR