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 03/03/2022

Event Type  Death  

Event Description

Fresenius became aware that this (b)(6) male patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) expired on (b)(6) 2022.It was unknown if there was any fresenius product(s) and/or device(s) involvement.No additional information was provided during intake.The patient¿s esrd death notification was received on 15/mar/2022, and revealed the patient expired on (b)(6) 2022.The patient¿s primary cause of death was a myocardial infarction (mi), and no secondary cause(s) was listed.Although the details provided are limited, it appears the patient experienced the mi while at home (timeline not provided).Attempts to obtain additional information (e.G., additional patient demographics, death certificate, treatment record) have thus far proven unsuccessful.

Manufacturer Narrative

Clinical review: it is unknown if a temporal relationship exists between ccpd therapy utilizing the liberty select cycler and the patient¿s serious adverse events of a mi and death, as it is unknown if the patient was undergoing ccpd therapy when the events occurred.However, the patient¿s esrd death notification indicates the primary cause of death was a mi, and no secondary cause was listed.The esrd population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population.Additionally, patients with esrd have a substantially higher incidence of acute coronary events (such as an mi), when compared to the general population.Based on the information available, the liberty select cycler can be disassociated from the events.There is no allegation or objective evidence indicating a fresenius product(s) and/or device(s) deficiency or malfunction caused and/or contributed to the patient¿s mi and subsequent death.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

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

Fresenius became aware that this 63-year-old male patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) expired on (b)(6).It was unknown if there was any fresenius product(s) and/or device(s) involvement.No additional information was provided during intake.The patient¿s esrd death notification was received on (b)(6) 2022, and revealed the patient expired on (b)(6)2022.The patient¿s primary cause of death was a myocardial infarction (mi), and no secondary cause(s) was listed.Although the details provided are limited, it appears the patient experienced the mi while at home (timeline not provided).Attempts to obtain additional information (e.G., additional patient demographics, death certificate, treatment record) have thus far proven unsuccessful.

Event Description

Fresenius became aware that this 63-year-old male patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) expired on (b)(6) 2022.It was unknown if there was any fresenius product(s) and/or device(s) involvement.No additional information was provided during intake.The patient¿s esrd death notification was received on 15/mar/2022, and revealed the patient expired on (b)(6) 2022.The patient¿s primary cause of death was a myocardial infarction (mi), and no secondary cause(s) was listed.Although the details provided are limited, it appears the patient experienced the mi while at home (timeline not provided).Attempts to obtain additional information (e.G., additional patient demographics, death certificate, treatment record) have thus far proven unsuccessful.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical inspection.A visual inspection of the returned cycler exterior showed no sign of physical damage.There were visual indications of dried fluid within the cassette compartment.There were no visual indication of particulates within the cassette area.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.The system air leak test passed.The valve actuation test passed.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.The cycler weighed fill volume values were within tolerance for a liberty cycler.The cycler was able to complete the treatment without issues.During an internal inspection of the returned cycler there were visual indications of dried fluid found underneath the pump assembly.There were no other visual discrepancies found during the internal a review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.

• 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: 13891576
• MDR Text Key: 287836238
• Report Number: 2937457-2022-00466
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2022

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?: Device Returned to Manufacturer
• Device Age: MO
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 03/24/2022; 04/25/2022
• Supplement Dates FDA Received: 04/06/2022; 05/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2018
• 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): Death
• Patient Age: 63 YR
• Patient Sex: Male