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 04/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow up mdr will be submitted upon completion of the plant's investigation.

Event Description

A peritoneal dialysis patient's contact reported that a fluid leak was noted during treatment.The cycler had alarmed for air detected in the cassette during drain 5 of 6 and treatment was discontinued.The patient found fluid leaking from the cassette.A follow up call was made, and it was reported that there was no adverse event related to the event.The set may be available for evaluation.

Manufacturer Narrative

The actual sample from the patient for evaluation on 05/10/2017 with lot number 16pr08116 with original package.A visual inspection was performed on the set.During the visual inspection the alleged failure was confirmed, a pin hole on the cassette film was found.The device history record [dhr] of this product was reviewed and no nonconformance reports or other abnormalities during the assembly of this lot were found.The product involved met specifications.

• 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: 6576730
• MDR Text Key: 75505592
• Report Number: 8030665-2017-00252
• 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 Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 06/08/2017

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: No Information
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 050-87212
• Device Lot Number: 16PR08116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Initial Date Manufacturer Received: 04/21/2017
• Initial Date FDA Received: 05/18/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2016
• 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 SOLUTION