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 Problem Leak/Splash (1354)

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

Event Date 01/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned to the manufacturer for physical evaluation, and the lot number was not able to be obtained to date.Distribution records were reviewed to identify potential lots of this product shipped to the customer over the past 3 months.The entire set of lots have been sold and distributed.Batch records for the lots identified were reviewed and confirmed there were no deviations or non-conformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.

Event Description

A peritoneal dialysis patient called technical services and stated during the treatment end process he removed the cassette from the liberty cycler and fluid had leaked out and into the cassette compartment.During follow-up with the patient he stated he was able to continue the treatment with replacement cycler without further issue.The patient confirmed his effluent had remained clear.No patient adverse events were experienced and no medical intervention was required as a result of this incident.The set was discarded.

• 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: 6294531
• MDR Text Key: 66322081
• Report Number: 8030665-2017-00037
• 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
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 01/11/2017
• 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
• Treatment: LIBERTY CYCLER; PD FLUID
• Patient Age: 67 YR
• Patient Weight: 82