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

Catalog Number 050-87216

Device Problems Partial Blockage (1065); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Peritonitis (2252)

Event Date 09/21/2017

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 patient's contact reported that the cycler displayed drain line is blocked.The contact stated that the patient was recently released from the hospital due to a peritonitis diagnosis.The patient's peritoneal start date is treatment at the hospital included cefapime and tobramycin.Per the peritoneal dialysis nurse, the outcome of the event is considered recovered.

Manufacturer Narrative

Corrective data: patient date of birth added.Catalog number added.

Event Description

A peritoneal patient's contact reported that the cycler displayed drain line is blocked.The contact stated that the patient was recently released from the hospital due to a peritonitis diagnosis.The patient's peritoneal start date is treatment at the hospital included cefapime and tobramycin.Per the peritoneal dialysis nurse, the outcome of the event is considered recovered.

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 patient's contact reported that the cycler displayed drain line is blocked.The contact stated that the patient was recently released from the hospital due to a peritonitis diagnosis.The patient's peritoneal start date is treatment at the hospital included cefapime and tobramycin.Per the peritoneal dialysis nurse, the outcome of the event is considered recovered.

Manufacturer Narrative

Corrective data: clinical evaluation: although a temporal relationship exists between the liberty cycler and the reported adverse event of peritonitis, there is no documentation showing a causal relationship between the liberty cycler and the adverse event of peritonitis.Additionally, there is no allegation against any fresenius products and the adverse event.It remains unclear if patient was utilizing any fresenius products during hospitalization.There is however a possible association between the reported peritonitis and a possible breach in aseptic technique during pd therapy or a possible association to a bowel source as this is known cause of peritonitis when related to a gram negative bacilli such as the patient¿s culture results revealed.

Event Description

A peritoneal patient's contact reported that the cycler displayed drain line is blocked.The contact stated that the patient was recently released from the hospital due to a peritonitis diagnosis.The patient's peritoneal start date is treatment at the hospital included cefapime and tobramycin.Per the peritoneal dialysis nurse, the outcome of the event is considered recovered.

Manufacturer Narrative

Corrective data: on follow up 3 should read 4/10/2018.On this report is 4/12/2018.

Event Description

A peritoneal patient's contact reported that the cycler displayed drain line is blocked.The contact stated that the patient was recently released from the hospital due to a peritonitis diagnosis.The patient's peritoneal start date is treatment at the hospital included cefapime and tobramycin.Per the peritoneal dialysis nurse, the outcome of the event is considered recovered.

Manufacturer Narrative

Corrective data: correction selected.Device code added.

Event Description

A peritoneal patient's contact reported that the cycler displayed drain line is blocked.The contact stated that the patient was recently released from the hospital due to a peritonitis diagnosis.The patient's peritoneal start date is treatment at the hospital included cefapime and tobramycin.Per the peritoneal dialysis nurse, the outcome of the event is considered recovered.

• 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: 6959829
• MDR Text Key: 89677223
• Report Number: 8030665-2017-00857
• Device Sequence Number: 1
• Product Code: FKX
• 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,Followup,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• 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?: No
• Device Age: MO
• Event Location: Home
• Date Manufacturer Received: 04/13/2018
• 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): Hospitalization; Other
• Patient Age: 31 YR