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 11/10/2016

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

While assisting a peritoneal dialysis (pd) patient with cancellation of treatment during fill 1 after the patient requested for a replacement cycler, the pd patient removed the tubing set and states there was condensation inside of the cycler door.The patient could not identify where the fluid was coming from the set was not made available for evaluation.During follow up he patient's perioneal dialysis nurse (pdrn) stated the patient had likely not set up the supplies properly, causing the fluid leak.Per pdrn the patient was not provided any prophylactic medication as a result of the reported instance, and a replacement cycler was delivered to the patient per the patient¿s request.

Manufacturer Narrative

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 nonconformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.

Event Description

While assisting a peritoneal dialysis (pd) patient with cancellation of treatment during fill 1 after the patient requested for a replacement cycler, the pd patient removed the tubing set and states there was condensation inside of the cycler door.The patient could not identify where the fluid was coming from the set was not made available for evaluation.During follow up he patient's peritoneal dialysis nurse (pdrn) stated the patient had likely not set up the supplies properly, causing the fluid leak.Per pdrn the patient was not provided any prophylactic medication as a result of the reported instance, and a replacement cycler was delivered to the patient per the patient¿s request.

• 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.; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA S.A. DE C.V.; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6139857
• MDR Text Key: 61296352
• Report Number: 8030665-2016-00589
• 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: 12/14/2016

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 Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Initial Date Manufacturer Received: 11/11/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2016
• 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: DELFLEX PD SOLUTION; LIBERTY CYCLER
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Weight: 71