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

Catalog Number	050-87222
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility peritoneal dialysis nurse (pdrn) reported that there was a split in the line of a patient's cassette causing liquid to leak all over the patient's floor during their peritoneal dialysis (pd) treatment.Upon follow up, the pdrn reported that during the patient¿s first dwell, a puddle of water was on the floor.The patient assessed the tubing and found that the patient line from the cassette had a leak.The leak appeared as a clean cut in the tubing.Per the pdrn, the patient stated that no scissors or knives were used near any of the cassettes when opening the box or package.The patient called the on-call nurse and the nurse gave them instructions to disconnect from treatment and to call their clinic first thing in the morning.There were no changes in the patient¿s status as it relates to the reported event.The patient¿s pd fluid was cultured and (b)(6) for any infection.The patient did not complete treatment on the day of the event, however resumed treatment the next day.The patient is reported to be stable and the product was scheduled to be picked up from the patient¿s home on the next supply delivery.
Additional Manufacturer Narrative
Plant investigation: the actual device was returned to the manufacturer for physical evaluation.During the disinfection of the complaint device, the alleged failure was confirmed.A leak was found in the patient line.A visual inspection was performed on the sample and there was damage noticed on the patient line.An investigation of the device history records (dhr) was conducted by the manufacturer.There were no nonconformances or abnormalities identified during the manufacturing process which could be associated with the reported event.In addition, the dhr review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the complaint was able to confirm the reported event.

• Brand Name: LIBERTY PDX, INTEGRATED SET
• Common Device Name: 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
• MDR Report Key: 7714559
• Report Number: 8030665-2018-01122
• Device Sequence Number: 1120725
• Product Code: FKX
• UDI-Device Identifier: 00840861101993
• UDI-Public: 00840861101993
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 050-87222
• Device Lot Number: 18ER08144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Device Age: MO
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; LIBERTY PDX CYCLER; DELFLEX PD FLUID; LIBERTY PDX CYCLER