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 Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2024

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak on the patient line (pl) during dwell 3 of 4 of treatment.There were no alarms/warnings prior to the leak.Fluid was not discovered in the pump module area or on the external of the cassette.The cause of the leak was a puncture on the line.The patient cancelled treatment and will follow up with their peritoneal dialysis nurse (pdrn).It was reported that an alternate treatment option was available.Upon follow up, the patient confirmed being restless prior to the reported event and that the patient line most likely snagged onto the edge of the bed frame when shifting position during the night.The patient's pdrn recommended draining into bags for 48 hours to ensure no signs of infection.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient skipped the remainder of treatment in the absence of the cycler.The patient is continuing with peritoneal dialysis on the cycler without issue and without reoccurrence of the reported event.The patient confirmed that the cycler set was discarded and not available to be returned to the manufacturer for physical evaluation.

Event Description

It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak on the patient line (pl) during dwell 3 of 4 of treatment.There were no alarms/warnings prior to the leak.Fluid was not discovered in the pump module area or on the external of the cassette.The cause of the leak was a puncture on the line.The patient cancelled treatment and will follow up with their peritoneal dialysis nurse (pdrn).It was reported that an alternate treatment option was available.Upon follow up, the patient confirmed being restless prior to the reported event and that the patient line most likely snagged onto the edge of the bed frame when shifting position during the night.The patient's pdrn recommended draining into bags for 48 hours to ensure no signs of infection.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient skipped the remainder of treatment in the absence of the cycler.The patient is continuing with peritoneal dialysis on the cycler without issue and without reoccurrence of the reported event.The patient confirmed that the cycler set was discarded and not available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

• 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.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 19163752
• MDR Text Key: 340826157
• Report Number: 0008030665-2024-00391
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2024

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
• Device Lot Number: 23KR08087
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 04/19/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2023
• 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; DELFLEX PD FLUID; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Sex: Male