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); Pulmonary Edema (2020); Hypervolemia (2664)

Event Date 01/31/2022

Event Type  Injury  

Event Description

It was reported by a peritoneal dialysis registered nurse [(pd)rn] that the pd patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler was hospitalized for fluid overload.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow up with the patient¿s pdrn, it was reported this patient was hospitalized on (b)(6) 2022 for fluid overload with pulmonary edema.The patient initially experienced dyspnea as a result of the pulmonary edema that was quickly resolved in the hospital.It was affirmed the patient did not experience dyspnea on around the time of a pd treatment.The patient¿s fluid overload with pulmonary edema resulting was caused by the patient not utilizing the appropriate dialysate solution during pd therapy.The patient only used 1.5% delflex solution when 2.5% delflex was recommended by the outpatient clinic.The patient was using a lesser strength dialysate solution which resulted in not removing enough fluid which accumulated over the course or multiple treatments.The patient was able to undergo ccpd therapy on a hospital provided cycler (unknown brand and model) for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2022.It was confirmed the patient¿s fluid overload with pulmonary edema, and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues ccpd therapy on the same liberty select cycler at home post-discharge.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: it was confirmed the patient¿s fluid overload with pulmonary edema, and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient¿s fluid overload with pulmonary edema resulting was caused by the patient not utilizing the appropriate dialysate solution during pd therapy.The patient only used 1.5% delflex solution when 2.5% delflex was recommended by the outpatient clinic.The patient was using a lesser strength dialysate solution which resulted in not removing enough fluid which accumulated over the course or multiple treatments.The patient continues ccpd therapy on the same liberty select cycler at home post-discharge.Based on the required information, there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue.

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-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 by a peritoneal dialysis registered nurse [(pd)rn] that the pd patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler was hospitalized for fluid overload.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow up with the patient¿s pdrn, it was reported this patient was hospitalized on (b)(6) 2022 for fluid overload with pulmonary edema.The patient initially experienced dyspnea as a result of the pulmonary edema that was quickly resolved in the hospital.It was affirmed the patient did not experience dyspnea on around the time of a pd treatment.The patient¿s fluid overload with pulmonary edema resulting was caused by the patient not utilizing the appropriate dialysate solution during pd therapy.The patient only used 1.5% delflex solution when 2.5% delflex was recommended by the outpatient clinic.The patient was using a lesser strength dialysate solution which resulted in not removing enough fluid which accumulated over the course or multiple treatments.The patient was able to undergo ccpd therapy on a hospital provided cycler (unknown brand and model) for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2022.It was confirmed the patient¿s fluid overload with pulmonary edema, and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues ccpd therapy on the same liberty select cycler at home post-discharge.

Event Description

It was reported by a peritoneal dialysis registered nurse [(pd)rn] that the pd patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler was hospitalized for fluid overload.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow up with the patient¿s pdrn, it was reported this patient was hospitalized on 31/jan/2022 for fluid overload with pulmonary edema.The patient initially experienced dyspnea as a result of the pulmonary edema that was quickly resolved in the hospital.It was affirmed the patient did not experience dyspnea on around the time of a pd treatment.The patient¿s fluid overload with pulmonary edema resulting was caused by the patient not utilizing the appropriate dialysate solution during pd therapy.The patient only used 1.5% delflex solution when 2.5% delflex was recommended by the outpatient clinic.The patient was using a lesser strength dialysate solution which resulted in not removing enough fluid which accumulated over the course or multiple treatments.The patient was able to undergo ccpd therapy on a hospital provided cycler (unknown brand and model) for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on 3/feb/2022.It was confirmed the patient¿s fluid overload with pulmonary edema, and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues ccpd therapy on the same liberty select cycler at home post-discharge.

• 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
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 14140785
• MDR Text Key: 289491055
• Report Number: 0002937457-2022-00642
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2022

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 04/20/2022; 04/27/2022
• Supplement Dates FDA Received: 04/26/2022; 05/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female