MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180343

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

Patient Problems Anemia (1706); Fatigue (1849); Pneumonia (2011); Hypervolemia (2664)

Event Date 10/06/2018

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is a temporal relationship between pd therapy on the liberty select cycler and the patient¿s hospitalization for anemia, pneumonia and a later diagnosis of fluid overload.According to the patient, the liberty select cycler kept malfunctioning which resulted in missed pd treatments, however, the patient was trained to complete capd and chose not to do so.The patient¿s anemia was an ongoing issue for which the patient¿s medication was altered to control.It is unknown if the missed pd treatments due to the issues reported by the patient and the pdrn caused the patient to be fluid overloaded and diagnosed with health care acquired pneumonia as the initial admitting diagnosis documented that there were no signs of fluid overload.It was in subsequent imaging during the hospitalization that the fluid overload was diagnosed.

Event Description

It was reported that a peritoneal dialysis (pd) patient's liberty select cycler kept malfunctioning which resulted in missed pd treatments, however, the patient was trained to complete manual therapy (capd) and chose not to do so.The patient was admitted to the hospital and treated for anemia, pneumonia, and fluid overload.The patient was discharged from the hospital and has successfully continued pd therapy.The cycler has been returned to the manufacturer for evaluation.

Event Description

A peritoneal dialysis registered nurse (pdrn) contacted technical support to request a replacement cycler for a patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt), as he continued to experience issues with his cyclers and had back to back replacements.The patient had previously had a replacement cycler delivered in response to a report of an out of box failure.Upon follow up, the patient contact reported that the cycler was working well, however the physician has requested that a new liberty select cycler be issued to this patient.Additional information was obtained through follow up with the pdrn and through medical records received 10/18/2018.The patient presented to the emergency room (er) on (b)(6) 2018 via emergency medical services (ems) with increased fatigue, general weakness, cough and subjective fevers along with dyspnea upon ambulation in setting of anemia with a hemoglobin of 7.4.The patient was on supplemental oxygen (unspecified).The patient reported to have been vacationing in canada (unknown dates) and missed two days of treatment due to difficulty with the cycler.Per the pdrn, the patient is trained on continuous ambulatory peritoneal dialysis (capd), however, chose not to complete capd therapy.The patient restarted pd therapy upon returning home.The patient also had decreased oral intake during this time.The patient denied experiencing nausea, vomiting and chills.There was no change in his pd fluid color or catheter (not a fresenius product) site, and later pd effluent cultures resulted negative.The patient was admitted to the hospital with diagnosis of health care acquired pneumonia as diagnosed on chest x-ray.The patient¿s white blood cell (wbc) count was 13.71 and was started on levaquin (route, dose, frequency and duration unknown).The patient has a past history of herpes simplex virus (hsv)/pneumocystis pneumonia (pcp) while being treated with immunosuppressive therapy for which he was currently taking prophylactic dapsone.The dapsone was discontinued.The patient¿s anemia was found to be multifactorial from end stage renal disease (esrd) as well as anemia of chronic disease.The patient received a transfusion of one unit of packed red blood cells (prbc) on (b)(6) 2018.The patient has a history of difficulties controlling the anemia.The patient was started on aranesp initially 200mcg subcutaneous every two weeks.No gastrointestinal (gi) bleed was found.The patient¿s dyspnea was likely secondary to the anemia as there were no signs of fluid overload on admission, however, in later documentation it was noted that a second chest x-ray completed on (b)(6) 2018 showed bilateral infiltrates likely to be fluid overload.The patient completed pd therapy during hospitalization, but it is unknown if fresenius products were utilized.The patient decided to transition to hemodialysis (hd), and nephrology was waiting for the patient¿s wbc count to return within normal limits in order to undergo catheter placement surgery, but there is no documentation to show that the transitioned to hd.The patient was discharged on (b)(6) 2018 and per the pdrn, he continues to complete pd therapy on the liberty select cycler.

Manufacturer Narrative

Additional information: event description.

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 SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8015209
• MDR Text Key: 125342265
• Report Number: 2937457-2018-03226
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 10/08/2018
• Initial Date FDA Received: 10/29/2018
• Supplement Dates Manufacturer Received: 10/18/2018; 02/12/2019
• Supplement Dates FDA Received: 11/02/2018; 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET ; DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention