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

Catalog Number 050-87216

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

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

Event Date 09/25/2017

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: this is a report of a patient who discovered a cassette leak during peritoneal dialysis therapy.As the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review and an investigation of the device history records (dhr) was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.In addition, the dhr review confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot 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 the complaint could not be confirmed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a peritoneal dialysis patient discovered that their cassette was leaking during drain 4 of 4 of peritoneal dialysis therapy.Prior to the discovery of the leak, the patient received an m31 air detected in cassette alarm from their liberty cycler.The patient had drained 1462ml of an expected 2303ml at the time of the alarm.The patient verified that the connection to the heater bag was secure.The technical support representative assisted the patient with reinitiating treatment but the alarm occurred three additional times.Upon further troubleshooting, the patient discovered that there was fluid under the cassette door.After removing the cassette, it was noted that there was a small hole identified on the cassette.The technical support representative advised the patient to discontinue use of the cycler due to the leak and to notify their peritoneal dialysis registered nurse of the event.The patient ended treatment early and their cycler was replaced.At the time of this report, there was no reported patient injury resulting from the incident.It was not reported if the patient completed treatment using manual supplies until their new cycler arrived.Additional information was requested but was unavailable.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• 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: 6952528
• MDR Text Key: 90399457
• Report Number: 8030665-2017-00844
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• 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: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/21/2020
• Device Catalogue Number: 050-87216
• Device Lot Number: 17ER08070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Initial Date Manufacturer Received: 09/25/2017
• Initial Date FDA Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2017
• 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