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 Problem Hypervolemia (2664)

Event Date 08/05/2022

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

On (b)(6) 2022, a peritoneal dialysis registered nurse [(pd)rn] reported this patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler was hospitalized following missed pd treatments.There was no specific allegation this event was directly 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 following fluid overload due to 4 days of missed pd treatments.The patient¿s liberty select cycler was inoperable for approximately one week prior to admission.The patient was trained to undergo continuous ambulatory pd (capd) therapy and had the appropriate supplies in her home; however, due to the patient¿s advancing age, she suffers from confusion and was unable to undergo capd.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 affirmed the patient¿s fluid overload was predicated on non-compliance to alternative pd therapy in the absence of an operable cycler.Additionally, it was confirmed the root cause of the patient¿s fluid overload was not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues ccpd therapy on a newly received liberty select cycler at home post-discharge.

Event Description

On (b)(6) 2022, a peritoneal dialysis registered nurse [(pd)rn] reported this patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler was hospitalized following missed pd treatments.There was no specific allegation this event was directly 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 following fluid overload due to 4 days of missed pd treatments.The patient¿s liberty select cycler was inoperable for approximately one week prior to admission.The patient was trained to undergo continuous ambulatory pd (capd) therapy and had the appropriate supplies in her home; however, due to the patient¿s advancing age, she suffers from confusion and was unable to undergo capd.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 affirmed the patient¿s fluid overload was predicated on non-compliance to alternative pd therapy in the absence of an operable cycler.Additionally, it was confirmed the root cause of the patient¿s fluid overload was not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues ccpd therapy on a newly received liberty select cycler at home post-discharge.

Manufacturer Narrative

Corrected information provided in d4.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.

Manufacturer Narrative

Corrected information provided in b1.

Event Description

On (b)(6) 2022, a peritoneal dialysis registered nurse [(pd)rn] reported this patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler was hospitalized following missed pd treatments.There was no specific allegation this event was directly 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 following fluid overload due to 4 days of missed pd treatments.The patient¿s liberty select cycler was inoperable for approximately one week prior to admission.The patient was trained to undergo continuous ambulatory pd (capd) therapy and had the appropriate supplies in her home; however, due to the patient¿s advancing age, she suffers from confusion and was unable to undergo capd.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 affirmed the patient¿s fluid overload was predicated on non-compliance to alternative pd therapy in the absence of an operable cycler.Additionally, it was confirmed the root cause of the patient¿s fluid overload was not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues ccpd therapy on a newly received 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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 15235225
• MDR Text Key: 297990538
• Report Number: 0002937457-2022-01366
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 90 YR
• Patient Sex: Female
• Patient Weight: 61 KG