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 Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device was returned to the manufacturer for physical evaluation and the complaint is confirmed.A visual inspection was performed and noticed a pin hole in the cassette film, no others issues were detected on tubing set.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.The device history file [dhr] of this product was reviewed and no nonconformance reports or other abnormalities were found.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.

Event Description

A peritoneal dialysis patient reported that the cycler alarmed with air detected in the cassette during drain 1 of 4.Treatment was cancelled.The patient found fluid leaking inside the cassette door.The patient¿s peritoneal dialysis registered nurse (pdrn) later confirmed that patient did not experience any adverse events.Prophylactic antibiotic cefazolin 1000 mg was prescribed.Patient did not complete treatment on the night of the event.The patient was performing continuous cycling peritoneal dialysis after that.The set was made available for evaluation.

• 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: 6368354
• MDR Text Key: 68768252
• Report Number: 8030665-2017-00085
• 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,health professional
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 050-87212
• Device Lot Number: 16HR08015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2016
• 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: DELFLEX PD FLUID; LIBERTY CYCLER
• Patient Age: 43 YR
• Patient Weight: 66