MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, DUAL PATIENT CONNECT; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number LIBERTY CYCLER SET, DUAL PATIENT CONNECT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Encephalopathy (1833); Pneumonia (2011); Sepsis (2067); Weakness (2145); Electrolyte Imbalance (2196); Peritonitis (2252)

Event Date 08/03/2018

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: there is a temporal relationship between the ccpd treatment with the liberty cycler/ liberty cycler set and the patient¿s adverse events of weakness, peritonitis, pneumonia, metabolic encephalopathy, electrolyte imbalance, and sepsis which required hospitalization.However, there have been no reported allegations of a fresenius product deficiency or malfunction associated with the patient¿s adverse events.Additionally, there is no objective evidence that the liberty cycler or liberty cycler set caused or contributed to the patient¿s peritonitis, pneumonia, metabolic encephalopathy, electrolyte imbalance and sepsis.There is no evidence of any fluid volume overload or other pd related precipitating factor.The patient has a past medical history of esrd and diabetes mellitus which are known to increase risk for the development of pneumonia.Additionally, the etiology for the patient¿s peritonitis event cannot be determined with the available information.However, there is no allegation or documentation that indicates the liberty cycler/ liberty cycler set caused or contributed to the patient¿s peritonitis event.Peritonitis is well known complication in patients on pd therapy.The patient¿s event of sepsis is most likely associated with the concurrent infections of pneumonia, uti and peritonitis.The patient¿s conditions of metabolic encephalopathy and electrolyte imbalance are likely associated with the patient¿s sepsis in the setting of esrd.Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported a patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) presented to the hospital with progressive generalized weakness over a period of two days, reports of intermittent chills, altered mental status and abdominal pain with concerns that her pd catheter (not a fresenius product) was not working.It was documented the pt.Was seen in the pd clinic prior to hospitalization and was hypoglycemic.It appears the patient¿s hypoglycemia resolved with unknown treatment by emergency medical services (ems) and the patient¿s glucose was 96 upon arrival to the hospital.Upon hospitalization, the patient was found to have sepsis related to left-sided pneumonia, urinary tract infection (uti) with escherichia coli and peritonitis.The patient was treated with intravenous (iv) zosyn (unknown dose, frequency and duration) to cover the pneumonia and intraperitoneal (ip) fortaz (unknown dose, frequency and duration) and vancomycin (unknown dose, frequency and duration).It was noted the patient¿s abdominal pain steadily improved; however, the patient¿s white blood cell (wbc) count was slow to respond to antibiotic therapy initially.Levofloxacin (unknown dose, route, frequency and duration) was added to the antibiotic regime for the treatment of her pneumonia and uti and the patient¿s wbc normalized.It was also noted in the patient¿s medical records that the patient had concurrent diagnosis of metabolic encephalopathy, hyponatremia (unknown sodium result) and hyperphosphatemia (unknown phosphorus result).However, there is no documentation of medical intervention necessary for these specific conditions.It is likely these events were related to the patient¿s esrd and overall sepsis.Per the patient¿s pd nurse, the patient did not miss any peritoneal dialysis treatments and dialysis continued during hospitalization (treatment and product details are unknown).The patient had continued weakness and was subsequently discharged a rehabilitation facility in stable condition on (b)(6) 2018 continuing on at least a 6-day course of oral levaquin for treatment of her pneumonia and uti.

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius liberty cycler sets shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr 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.

Event Description

• Brand Name: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• 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: 7800465
• MDR Text Key: 117693625
• Report Number: 8030665-2018-01269
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100736
• UDI-Public: 00840861100736
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• Device Catalogue Number: 050-87212
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 08/23/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 55 YR