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

Catalog Number UNKNOWN- FMC CASSETTE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Peritonitis (2252)

Event Date 06/19/2017

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer.A supplemental report will be filed upon completion of the manufacturer's investigation.

Event Description

A peritoneal dialysis patient reported that the cycler displayed a drain complication and was unable to bypass.The patient set up with new supplies.During a follow up phone call to the patient's nurse, it was reported that the patient got peritonitis on (b)(6) 2017 and was given a 14 day treatment of fortaz in his solution.The culture was taken and the results showed (acinetobacter baumannii).The patient was able to complete treatment the time of the call after contacting the rn.She assisted the patient with completing with medicated solution without further issues.The patient is still recovering.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.

Event Description

A peritoneal dialysis patient reported that the cycler displayed a drain complication and was unable to bypass.The patient set up with new supplies.During a follow up phone call to the patient's nurse, it was reported that the patient got peritonitis on (b)(6) 2017 and was given a 14day traetment of fortaz in his solution.The culture was taken and the results showed (acinebacter baumanni).The patient was able to complete treatment the time of the call after contacting the rn.She assisted the patient with completing with medicated solution without further issues.The patient is still recovering.

Manufacturer Narrative

Clinical evaluation: there is no documentation that shows a causal relationship between the event of peritonitis and the liberty cycler.Additionally, there is no allegation against any fresenius products and the event.

Event Description

A peritoneal dialysis patient reported that the cycler displayed a drain complication and was unable to bypass.The patient set up with new supplies.During a follow up phone call to the patient's nurse, it was reported that the patient got peritonitis on (b)(6) 2017 and was given a 14day traetment of fortaz in his solution.The culture was taken and the results showed (acinebacter baumanni).The patient was able to complete treatment the time of the call after contacting the rn.She assisted the patient with completing with medicated solution without further issues.The patient is still recovering.

• Brand Name: LIBERTY CYCLER SET
• 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: 6852797
• MDR Text Key: 85439275
• Report Number: 8030665-2017-00666
• Device Sequence Number: 1
• Product Code: FKC
• 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
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN- FMC CASSETTE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Event Location: Home
• Initial Date Manufacturer Received: 06/29/2017
• Initial Date FDA Received: 09/08/2017
• Supplement Dates Manufacturer Received: 10/13/2017; 07/14/2017
• Supplement Dates FDA Received: 11/11/2017; 01/31/2018
• 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
• Treatment: LIBERTY CYCLER; PD FLUID
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 107