MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180343

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Pneumonia (2011); Pulmonary Edema (2020)

Event Date 11/29/2023

Event Type  Injury  

Event Description

On 29/nov/2023 this peritoneal dialysis patient¿s spouse contacted fresenius technical support for assistance in canceling the treatment on the liberty select cycler.The patient was in fill 2 of 4 and experiencing chest pains.The patient required going to the emergency room (er).Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was in treatment on the reported date when she suddenly complained of chest pain and not feeling well.The patient asked her spouse to take her to the hospital.Technical support assisted the patient in discontinuing the treatment and 911 was called.The patient was transported via emergency medical services (ems) to the hospital.The patient was admitted to the intensive care unit (icu) with a diagnosis of flash pulmonary edema.The patient is out of the icu but remains lethargic and slightly confused.The flash pulmonary edema was possibly caused by pneumonia.The medical team is planning to treat the patient with antibiotics.The patient continues to complete pd therapy during the hospitalization.Prior to the event, the patient¿s spouse stated she was alert and oriented to person, place, and time and doing fine.The spouse stated the patient has a history of chest pains.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: there is a temporal relationship between peritoneal dialysis utilizing the liberty select cycler and the patient event of chest pains during treatment with subsequent hospitalization for flash pulmonary edema.However, there is no documentation to show a causal relationship between the adverse event and use of the liberty select cycler.Additionally, there is no allegation of a device malfunction or deficiency reported for this event.The patient was diagnosed with flash pulmonary edema.Flash pulmonary edema is a type of acute pulmonary edema and a particularly dramatic form of acute decompensated heart failure.While heart conditions like congestive heart failure are a common cause of pulmonary edema, other potential causes include pneumonia, trauma, inhalation of toxic chemicals, and certain medications.The suggested cause of the patient¿s flash pulmonary edema is pneumonia.Based on the available information and no evidence or allegation or a malfunction or deficiency, the liberty select cycler can be excluded as the cause of the patient¿s chest pains with hospitalization for flash pulmonary edema.

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

On 29/nov/2023, this peritoneal dialysis patient¿s spouse contacted fresenius technical support for assistance in canceling the treatment on the liberty select cycler.The patient was in fill 2 of 4 and experiencing chest pains.The patient required going to the emergency room (er).Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was in treatment on the reported date when she suddenly complained of chest pain and not feeling well.The patient asked her spouse to take her to the hospital.Technical support assisted the patient in discontinuing the treatment and 911 was called.The patient was transported via emergency medical services (ems) to the hospital.The patient was admitted to the intensive care unit (icu) with a diagnosis of flash pulmonary edema.The patient is out of the icu but remains lethargic and slightly confused.The flash pulmonary edema was possibly caused by pneumonia.The medical team is planning to treat the patient with antibiotics.The patient continues to complete pd therapy during the hospitalization.Prior to the event, the patient¿s spouse stated she was alert and oriented to person, place, and time and doing fine.The spouse stated the patient has a history of chest pains.

• 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: 18294520
• MDR Text Key: 330111957
• Report Number: 0002937457-2023-01851
• 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: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2017
• 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; LIBERTY CYCLER SET ; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 54 KG