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

Model Number 180343

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

Patient Problems Dyspnea (1816); Inflammation (1932)

Event Date 05/30/2020

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, liberty select set and this event of hospitalization with associated symptoms of shortness of breath and swelling of the extremities.It is well established that contributory comorbidities including diabetes and coronary arterial disease can put the pd patient at risk for an exacerbation of cardiac disease.The cause of the patient¿s symptoms cannot be determined at this time.Due to the evidence of cardiac diagnostic testing during this hospitalization and the patient¿s history of coronary arterial disease, it is well within reason to assume the patient¿s symptoms and associated hospitalization may be due to a worsening of inherent cardiac disease.Based on the available information, there is no specific allegation or objective evidence indicating a fresenius device(s) or product(s) deficiency or malfunction, caused or contributed to the patient¿s serious adverse events.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 was hospitalized due to shortness of breath and swelling.Upon follow up, the patient¿s pd registered nurse (pdrn) reported the patient was admitted to the hospital for shortness of breath and swelling of extremities.It was reported the patient had not undergone ccpd on the liberty select cycler for two days prior to this hospitalization due to unspecified technical difficulties on a new cycler the patient recently received.Additionally, the patient¿s delflex strength had recently been increased from 1.5% to 2.5% due to large urine outputs.There has not been a determination on the etiology of the shortness of breath and extremity swelling at the time of this clinical review and it was reported the patient has been undergoing cardiac diagnostic testing during this admission.The patient was able to undergo ccpd therapy on the liberty select cycler during the hospital stay without incident.It was reported by the pdrn the patient¿s shortness of breath, swelling of extremities and associated hospitalization were ¿more than likely¿ not due to any deficiency or malfunction of the liberty select cycler or any fresenius product(s) or device(s).The patient is recovering from this event and awaiting discharge with plans to continue ccpd therapy with the new liberty select cycler at home post-discharge.

Manufacturer Narrative

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-conformance's, 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.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 10138735
• MDR Text Key: 194994710
• Report Number: 2937457-2020-01037
• 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: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR
• Patient Weight: 136