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 Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem Peritonitis (2252)

Event Date 12/22/2017

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.There is no documentation in the complaint file supporting an association between the liberty cycler or the liberty cycler set and the event of peritonitis.Additionally, there is no allegation for this time period against any fresenius devices in relation to this event.However, in light of the pd nurse reporting the adverse event was attributed to touch contamination; a strong likely relationship with breaks in aseptic technique during pd treatments and the resulting episode of peritonitis exists.

Event Description

A peritoneal dialysis patient's nurse reported the patient utilizing continuous cyclic peritoneal dialysis [cc(pd)] therapy for renal replacement therapy (rrt) presented to the pd clinic on (b)(6) 2017 with a cloudy effluent bag.The patient was diagnosed with peritonitis with reported growth of coagulase negative staphylococcus.According to the patients nurse the event was attributed to a breach in technique (details unknown).The patient was not hospitalized and was prescribed antibiotics levofloxacin and vancomycin (route, dose and duration unknown).Accordingly, the patient 's peritonitis has cleared with white blood cells (wbc) reducing (level unknown) in subsequent effluent checks.The patient was not hospitalized for the event.

• 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: 7217543
• MDR Text Key: 98162041
• Report Number: 8030665-2018-00131
• 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
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• 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: 01/05/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 74