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 Uremia (2188); Hypervolemia (2664)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported through a clinic survey that a peritoneal dialysis (pd) patient was recently hospitalized.The patient kept holding more and more water until it eventually reached their lungs and filled around their heart.The patient was hospitalized for 8 days and did hemodialysis (hd) in the hospital.After patient got out of the hospital, they went back to pd and in just over a week, was rushed to the hospital again for a 6 day stay where a huge needle was stuck in their chest and all the blood and fluid was removed from around their heart.Patient had just started feeling better on hd when they were switched over to pd and they started feeling worse by the day.Patient was on pd for a little over a month including the two hospital stays for 6 and 8 days.Upon follow up, the patient¿s dietician reported the patient was initially completing in-center hemodialysis in december 2020 when then the patient switched modality to home pd in january 2021 (date unknown).While on pd therapy, the dietician reported the patient was non-compliant with treatment.The patient never completed a full treatment while on continuous cycling peritoneal dialysis (ccpd).The patient was non-compliant with dietary restrictions and recommendations.The patient also continued to take protein supplements while on dialysis.This non-compliance resulted in the patient frequently being fluid overloaded and uremic.Dates of the patient¿s hospitalizations were unavailable; however, it was confirmed that the liberty select cycler, nor any fresenius product was the cause of the patient¿s adverse events.The patient¿s non-compliance was the cause.The patient had planned to transition to home hd, but that did not occur (reason unknown).The patient has returned to in-center hd as of 29/mar/2021 and remains non-compliant.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.

Event Description

It was reported through a clinic survey that a peritoneal dialysis (pd) patient was recently hospitalized.The patient kept holding more and more water until it eventually reached their lungs and filled around their heart.The patient was hospitalized for 8 days and did hemodialysis (hd) in the hospital.After patient got out of the hospital, they went back to pd and in just over a week, was rushed to the hospital again for a 6 day stay where a huge needle was stuck in their chest and all the blood and fluid was removed from around their heart.Patient had just started feeling better on hd when they were switched over to pd and they started feeling worse by the day.Patient was on pd for a little over a month including the two hospital stays for 6 and 8 days.Upon follow up, the patient¿s dietician reported the patient was initially completing in-center hemodialysis in december 2020 when then the patient switched modality to home pd in january 2021 (date unknown).While on pd therapy, the dietician reported the patient was non-compliant with treatment.The patient never completed a full treatment while on continuous cycling peritoneal dialysis (ccpd).The patient was non-compliant with dietary restrictions and recommendations.The patient also continued to take protein supplements while on dialysis.This non-compliance resulted in the patient frequently being fluid overloaded and uremic.Dates of the patient¿s hospitalizations were unavailable; however, it was confirmed that the liberty select cycler, nor any fresenius product was the cause of the patient¿s adverse events.The patient¿s non-compliance was the cause.The patient had planned to transition to home hd, but that did not occur (reason unknown).The patient has returned to in-center hd as of 29/mar/2021 and remains non-compliant.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.As a serial number could not be determined, device history and manufacturing records could not be reviewed.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; 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 12700228
• MDR Text Key: 278620315
• Report Number: 2937457-2021-02143
• 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: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• 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: 11/09/2021
• 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; LIBERTY CYCLER SET; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male