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

Catalog Number 050-87215

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

Patient Problem Peritonitis (2252)

Event Date 07/17/2017

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

A peritoneal dialysis (pd) patient reported cloudy effluent.During follow up the patient's pd nurse (pdrn) reported patient had peritonitis, and was being treated with a 21 day course of cefazolin.Pdrn stated that the patient was not hospitalized, and that the peritonitis was due to touch contamination.The culture results yielded coagulase negative staph colonization.Pdrn stated that the patient did not experience any abdominal pain and did not have any other symptoms of infection.

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 no documentation that shows a causal relationship between the cassette the event of peritonitis.There is no allegation against any fresenius products.There is a probable association between the peritonitis and a breach in aseptic technique during at home pd therapy.Should additional new information be made available this clinical investigation will be reevaluated.

Event Description

Peritoneal dialysis nurse reported this (b)(6) peritoneal dialysis patient was diagnosed with peritonitis.Pd fluid was cultured with gram negative coagulase-negative staphylococci cultures on (b)(6) 2017.Collection date is unknown.Patient was treated with cefazolin (initially reported as ceftazidine and vancomycin) for 21 days.Patient did not experience any abdominal pain or signs and symptoms of infection.Patient continued treatment without any changes.It was indicated that the patient was not performing treatment with proper aseptic technique.,.

• Brand Name: LIBERTY CYCLER SET, SINGLE PATIENT CONN
• 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: 6808998
• MDR Text Key: 83193815
• Report Number: 8030665-2017-00597
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100743
• UDI-Public: 00840861100743
• 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: 08/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 09/25/2017
• 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): Required Intervention
• Patient Age: 52 YR