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 05/01/2022

Event Type  Death  

Manufacturer Narrative

Clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, and the patient¿s serious adverse events of an mi and death.Although the patient¿s cause of death was reportedly due to an mi, the cause of the mi is unknown; therefore, causality could not firmly be established.During follow-up the pdrn did not allege any fresenius device(s) and/or product(s) involvement.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 cannot be disassociated from the events.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction caused the serious adverse events.However, given the lack of information (e.G., esrd death notification, definitive causality, death certificate, treatment data), the liberty select cycler cannot be excluded from having a possible causal or contributory role in the serious adverse events.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A relative of a peritoneal dialysis (pd) patient reported that the patient expired while undergoing continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt).During follow-up, a pd registered nurse (pdrn) confirmed the patient expired on (b)(6) 2022 due to a myocardial infarction (mi).Subsequent attempts to obtain additional information (e.G., discharge summary, treatment record, death certificate, esrd death notification) have thus far proven unsuccessful.

Manufacturer Narrative

Additional information: g.1.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

A relative of a peritoneal dialysis (pd) patient reported that the patient expired while undergoing continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt).During follow-up, a pd registered nurse (pdrn) confirmed the patient expired on (b)(6) 2022 due to a myocardial infarction (mi).Subsequent attempts to obtain additional information (e.G., discharge summary, treatment record, death certificate, esrd death notification) have thus far proven unsuccessful.

Event Description

A relative of a peritoneal dialysis (pd) patient reported that the patient expired while undergoing continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt).During follow-up, a pd registered nurse (pdrn) confirmed the patient expired on (b)(6) 2022 due to a myocardial infarction (mi).Subsequent attempts to obtain additional information (e.G., discharge summary, treatment record, death certificate, esrd death notification) have thus far proven unsuccessful.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.A visual inspection of the returned cycler exterior showed no sign of physical damage.Valve actuation test passed.System air leak test passed.Teach pump test passed.An (as-received) simulated treatment was performed and completed without failures.The cycler weighed fill volume values were within tolerance for a liberty cycler.The cycler was able to complete the treatment without issues.There were no visual discrepancies encountered during the internal inspection.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.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.

• 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: 14411755
• MDR Text Key: 291754290
• Report Number: 0002937457-2022-00783
• 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,Followup
• Report Date: 09/09/2022

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: 05/01/2022
• Initial Date FDA Received: 05/16/2022
• Supplement Dates Manufacturer Received: 05/20/2022; 09/09/2022
• Supplement Dates FDA Received: 06/01/2022; 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2017
• 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): Death
• Patient Sex: Female