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 Myocardial Infarction (1969)

Event Date 10/13/2022

Event Type  Death  

Event Description

It was reported by medical personnel that a peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler passed away while hooked up to a cycler.There was no specific allegation this event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with the patient¿s pd nurse, it was reported this patient expired at home on (b)(6) 2022 due to a myocardial infarction (mi).It was affirmed the patient was connected to his liberty select cycler at the time of death.The patient was found unresponsive at home by family and emergency medical services (ems) were activated.Upon ems arrival to the patient¿s home, he was pronounced deceased and was not transported.The patient had a significant history of cardiac disease including cardiac arrhythmias with an implanted pacemaker and defibrillator prior to this event.It was confirmed the patient¿s mi leading to his death was unrelated to pd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).

Manufacturer Narrative

Clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler and the patient¿s mi leading to his death.The cause of the patient¿s mi can be attributed to a significant cardiac disease history as reported by a medical professional.It is well known the esrd population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population, particularly in the environment of cardiac disease.Therefore, the liberty select cycler can be excluded as a root cause or contributor to this patient¿s adverse event.Based on the required 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 adverse events.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported by medical personnel that a peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler passed away while hooked up to a cycler.There was no specific allegation this event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with the patient¿s pd nurse, it was reported this patient expired at home on (b)(6) 2022 due to a myocardial infarction (mi).It was affirmed the patient was connected to his liberty select cycler at the time of death.The patient was found unresponsive at home by family and emergency medical services (ems) were activated.Upon ems arrival to the patient¿s home, he was pronounced deceased and was not transported.The patient had a significant history of cardiac disease including cardiac arrhythmias with an implanted pacemaker and defibrillator prior to this event.It was confirmed the patient¿s mi leading to his death was unrelated to pd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).

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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 15709033
• MDR Text Key: 302784308
• Report Number: 0002937457-2022-01842
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• 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: 11/29/2022
• 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; LIBERTY CYCLER SET; LIBERTY CYCLER SET
• Patient Outcome(s): Death
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 81 KG