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

Patient Problem Peritonitis (2252)

Event Date 10/01/2017

Event Type  Injury  

Manufacturer Narrative

Specific date of event unknown, defaulted to (b)(6) 2017 a possible temporal association exists between the liberty cycler set and the patient¿s hospitalization for pseudomonas peritonitis requiring removal of the patient¿s pd catheter (not a fresenius product) and transition to hd therapy.However, there is no documentation in the complaint file that indicates the liberty cycler set caused the patient¿s pseudomonas peritonitis.Pseudomonas bacteria are found in soil, water, plants and animals, including humans.Pseudomonas infections are often severe and associated with the pd catheter, frequently resulting in pd catheter removal and permanent transfer for hd therapy.A strong possible association exists between a breach in aseptic technique and the pt¿s pseudomonas peritonitis infection.A follow up will be submitted following evaluation.

Event Description

It was reported this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis (ccpd) therapy was hospitalized with pseudomonas.Details of hospitalization course are unknown.The patient had their pd catheter removed (unknown date) and was discharged from the hospital (unknown date) and began on in-center hemodialysis (hd) therapy on (b)(6) 2017.Additionally, the home dialysis program manager reported (during a follow up call on (b)(6) 2017) the patient was instructed to bleach the showerhead and the patient may not have been adhering to this practice.Furthermore, it was stated the patient¿s pseudomonas peritonitis was related to a breach in aseptic technique.

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.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
• 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: 7051519
• MDR Text Key: 92715313
• Report Number: 8030665-2017-01016
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100736
• UDI-Public: 00840861100736
• 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: consumer,health professional
• 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: 11/21/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/22/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR