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

Device Problems Fluid/Blood Leak (1250); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

A: patient information was not provided at the time the event was reported.Product information was not provided at the time the event was reported.Patient information was not provided at the time the event was reported.The reported set was not made available.The lot number and the product code number of the set used are unknown as it was not provided and cannot be determined.A set is not released unless the labeling, material, and process controls were within specification.Additional information cannot be solicited at this time.A supplemental report will be submitted upon receipt of additional information.

Event Description

A peritoneal dialysis (pd) patient reported to have broken the connection to her stay safe connector by walking away from the cycler because she had forgotten she was connected to it.Fluid leaked out of the patient line as a result of incident.No fluid came into contact with the cycler.The patient contact was referred to their pd nurse or clinic for further inspection of the patient's catheter.Patient information and product information was not provided.

• 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: 6619822
• MDR Text Key: 76972418
• Report Number: 8030665-2017-00302
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 05/10/2017
• 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