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 Edema (1820); Myocardial Infarction (1969); Nausea (1970); Vomiting (2144)

Event Date 04/09/2020

Event Type  Injury  

Manufacturer Narrative

Clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler and the patient¿s adverse events of nausea, vomiting, and swelling/edema which warranted hospitalization and surgical intervention.The cause of the mi was attributed to the patient¿s cardiac history, and two occluded arteries which required stenting.The cause of the patient¿s nausea, vomiting and hypervolemic state is unknown; therefore, causality cannot be firmly established.However, given the patient¿s decreased cardiac output and lower extremity swelling/edema, it is reasonable to conclude the patient¿s hypervolemic state was, in part, caused by the patient¿s changes in cardiovascular health.Nevertheless, based on the limited information available, the liberty select cycler cannot be excluded from having a possible contributory role in the events.Given the events partially occurred during ccpd therapy, the lack of a discharge summary, no treatment data, no past medical history and no manufacturer investigation (device not returned) into the suspect device.There is insufficient evidence to substantiate a disassociation of the device from the events.Fluid overload and hypervolemia are common and often preventable processes.Many factors such as non-compliance, inappropriate prescription, loss of residual renal function, mechanical problems and peritoneal membrane failure are all possible contributing factors.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A paramedic contacted fresenius technical support requesting assistance discontinuing continuous cyclic peritoneal dialysis (ccpd) for a patient.The paramedic reported the patient was going to be taken to the hospital.Follow-up with the patient and patient¿s daughter, revealed the patient was hospitalized from (b)(6) 2020 due to nausea, vomiting and a myocardial infarction (mi), which occurred during ccpd therapy on (b)(6) 2020.The patient experienced an mi due to ¿clogged arteries¿ (specifics not provided).The patient underwent a cardiac catheterization, where two stents were successfully placed.One of the patient¿s arteries was 99% occluded and another was 98% occluded (specifics not provided).The patient¿s daughter reported the patient was approximately 4.5 kgs above their estimated dry weight (dry weight not provided) and received two ccpd treatments utilizing primarily a 4.25% dextrose solution.The daughter had no knowledge if the patient was diagnosed with ¿fluid overload,¿ however the patient¿s lower extremities were visibly swollen.The patient was discharged and resumed ccpd therapy on the same liberty select cycler as before the events.Additional information was requested, however to date has not been provided.

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-conformance's, 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.

• 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
• MDR Report Key: 9979046
• MDR Text Key: 188643231
• Report Number: 2937457-2020-00706
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 04/09/2020
• Initial Date FDA Received: 04/20/2020
• Supplement Dates Manufacturer Received: 04/27/2020
• Supplement Dates FDA Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention