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 Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problems Hernia (2240); Peritonitis (2252)

Event Date 08/20/2017

Event Type  Injury  

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 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 reported he had been in the hospital for an undisclosed reason.During follow up the patient's nurse reported the patient was hospitalized from (b)(6) 2017 for peritonitis and a hernia.The patient's peritonitis was attributed to touch contamination.The patient was prescribed antibiotic vancomycin.The patient also uses gentamicin drops near the catheter exit site.Specific culture results were not available.While hospitalized it was noted that the patient's pre-existing hernia had become more prominent.The patient's fill volumes were decreased from 2500 to 1500 ml.The patient will be scheduled for a hernia repair at a later date.The set was not made available for evaluation.

Manufacturer Narrative

Clinical investigation: there is a likely temporal association between the liberty cycler and the patient¿s peritonitis event requiring subsequent hospitalization.Although, there is no documentation in the complaint file to support a causal relationship.Additionally, there have been no reported allegations against a liberty cycler set malfunction associated with the causal relationship to the patient¿s peritonitis event.Furthermore, there is a probable causal association between the patient¿s reported touch contamination during continuous cyclic peritoneal dialysis (ccpd) treatment and the patient¿s peritonitis event.Additionally, there is a temporal association between ccpd therapy with the liberty cycler and the patient¿s reported exacerbation of a pre-existing hernia.Although, there have been no reported allegations of a liberty cycle malfunction that is casually related to the patient¿s hernia event.It is known that increased intra-abdominal pressure during pd therapy (due to the dialysate) may create or exacerbate pre-existing weaknesses in the supporting abdominal wall structures and lead to hernia formation.Therefore, the liberty cycler used for ccpd therapy cannot be excluded as a possible contributory/casual factor in the patient¿s hernia exacerbation.

• 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: 6921181
• MDR Text Key: 88405067
• Report Number: 8030665-2017-00803
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• 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: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 10/12/2017
• 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: DELFLEX PD FLUID; LIBERTY CYCLER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR