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 01/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A supplemental mdr will be submitted upon the completion of plant investigation.

Event Description

Peritoneal dialysis patient reported the cycler alarmed for drain line blocked and for air detected in the cassette during drain 2 of 4.Treatment was discontinued.The cassette was taken out and fluid was found leaking from inside the cassette door.The patient¿s nurse later confirmed that the leak did not result in any adverse events.Prophylactic antibiotics were not prescribed.Culture tests were not performed.The patient missed one treatment on the day of the event.The patient resumed continuous cycler-assisted peritoneal dialysis after that.The set may be made available for evaluation.

Manufacturer Narrative

The actual device was returned to the manufacturer for physical evaluation and the complaint is confirmed.A visual inspection was performed and noticed damage on film cassette, no others issues were detected on tubing set.After visual inspection the cassette was inspected with the microscope and learned that the damage was one pinhole, no damage on the hard plastic was found.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 during the assembly of this lot were found.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.

• 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: 6337182
• MDR Text Key: 67657503
• Report Number: 8030665-2017-00066
• 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,Followup
• Report Date: 03/08/2017

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: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 050-87216
• Device Lot Number: 16LR08023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Initial Date Manufacturer Received: 01/22/2017
• Initial Date FDA Received: 02/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2016
• 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: 74 YR
• Patient Weight: 94