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 Dyspnea (1816); Hypoxia (1918); Pneumonia (2011); Pulmonary Edema (2020); Hypervolemia (2664)

Event Date 11/24/2018

Event Type  Injury  

Manufacturer Narrative

Clinical review: a clinical investigation was performed.A temporal relationship exists between ccpd therapy utilizing the liberty select cycler and the event(s) of hypoxia, fluid retention, pe and fo which warranted hospitalization.The etiology of the event(s) is unknown; therefore, causality cannot be determined.However, those persons undergoing pd therapy are known to have a higher incidence of fluid overload.Given the limited information available, the liberty select cycler cannot be disassociated from the event.The liberty select cycler was not returned to the manufacturer for evaluation.As such, the liberty select cycler cannot be excluded from having a possible causal or contributory role in the event(s).Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (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 reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

It was reported that a peritoneal dialysis (pd) patient was hospitalized on (b)(6) 2018 due to low oxygen level, water in the lungs, and retaining fluid.Upon follow up, pdrn stated that patient was discharged on (b)(6) 2018.Rn confirmed the events and attributed pulmonary edema, hypoxia, and fluid retention to fluid overload.Rn was unaware of the treatment given in the hospital.Rn believes it was not related to the cycler.Pd therapy continued in the hospital and post discharge.

Event Description

The discharge summary was received and revealed the patient was evaluated in the emergency room (er) on for a non-productive cough, poor appetite, worsening shortness of breath (sob) and orthopnea.The patient¿s vital signs were reportedly stable, however a decrease in oxygen saturation (87%) was noted when the patient was supine.A chest x-ray performed in the er showed pulmonary congestion with bilateral trace pleural effusion and possible infiltrates on right lower lobe.The patient¿s spouse reported the patient was utilizing manual pd exchanges for approximately 1 week while waiting for a replacement liberty select cycler.The patient was given one-time doses of intravenous (iv) azithromycin (dosage and route not provided), iv lasix 80mg, ativan 0.5mg (route not provided) and was admitted for hypoxia.It was initially felt the patient was hypervolemic due to missed pd therapy; however, the patient¿s symptoms continued despite inpatient pd therapy.The patient was subsequently treated with azithromycin (route, dosage, frequency and duration not provided) and diagnosed with atypical pneumonia or a viral syndrome.The patient was also found to be moderately constipated and was started on a bowel regimen with ¿some¿ success.The patient was discharged in stable condition and given an order to follow-up with a gastroenterologist concerning the chronic nausea and constipation likely due to gastroparesis.It is unknown if any fresenius product(s) or device(s) were utilized during the hospitalization; however, it is known that pd therapy continued during the hospital stay.

Manufacturer Narrative

Clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, and the patient¿s adverse event(s) of non-productive cough, poor appetite, dyspnea, orthopnea, hypoxia and atypical pneumonia/viral syndrome which warranted hospitalization.The reported cause of the patient¿s non-productive cough, poor appetite, dyspnea, orthopnea, hypoxia were caused by atypical pneumonia or a viral syndrome.The cause of the atypical pneumonia or viral syndrome is unknown; therefore, causality cannot be established.Based on the available information, there is no indication the liberty select cycler caused or contributed to the adverse event(s).During follow-up, the pdrn stated the event(s) were unrelated to the liberty select cycler.Additionally, there is no evidence of a malfunction or of the machine failing to perform as expected in relation to this event.Furthermore, the patient continues to utilize the same liberty select cycler without any reported issues or allegations of machine malfunction or deficiency.Should additional information become available, the need for a revised clinical investigation will be re-evaluated accordingly.

• 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: 8145813
• MDR Text Key: 129750114
• Report Number: 2937457-2018-03618
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 12/19/2018
• 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
• Patient Age: 56 YR