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); Hemorrhage/Bleeding (1888); Overdose (1988); Convulsion/Seizure (4406)

Event Date 07/16/2023

Event Type  Death  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: a temporal relationship does not exist between ccpd therapy utilizing the liberty select cycler, and the patient¿s serious adverse events of overdose (characterized by chest pain and seizure), as the patient completed pd therapy > 4 hours prior to the onset of the chest pain.The patient was hospitalized, intubated, and later underwent a tracheostomy which led to an arterial rupture and subsequent death.The patient¿s cause of death was reported as hemorrhage due to surgery.Per the pdrn, the serious adverse events were unrelated to any fresenius device(s) and/or product(s).Based on the information available, the liberty select cycler can be disassociated from serious adverse events.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) caused and/or contributed to the serious adverse events.Furthermore, there was no report a fresenius product(s) and/or device(s) failed to meet the users¿ expectations or manufacturers¿ specifications.

Event Description

On 4/aug/2023, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized.No additional information was provided during intake.During follow-up, the pd registered nurse (pdrn) confirmed the patient was hospitalized on (b)(6) 2023 after experiencing chest pain (occurred midday, completed dialysis >4 hours prior).The pdrn stated the patient was being treated for an ear infection and was improperly consuming her antibiotics (drug, dose, frequency, duration unknown) which led to an overdose.Upon arrival at the emergency room the patient began having seizures and was transported to the intensive care unit, where she required intubation.On (b)(6) 2023 the patient was transitioned to hemodialysis (hd) due to her critical status, without reported issue.Over the next 15 days the patient¿s pd catheter (not a fresenius product) was removed, a permanent hd catheter (not a fresenius product) was placed, a percutaneous endoscopic gastrostomy (peg) tube (not a fresenius product) was inserted for nutrition and the patient underwent the placement of a tracheostomy tube (not a fresenius product).On (b)(6) 2023, the patient experienced a severe arterial rupture at the tracheotomy site and the bleeding could not be controlled.The patient¿s primary cause of death was hemorrhage from surgery.The pdrn stated the serious adverse events were unrelated to the patient¿s utilization of any fresenius device(s) and/or product(s).

Event Description

On 4/aug/2023, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized.No additional information was provided during intake.During follow-up, the pd registered nurse (pdrn) confirmed the patient was hospitalized on (b)(6) 2023 after experiencing chest pain (occurred midday, completed dialysis >4 hours prior).The pdrn stated the patient was being treated for an ear infection and was improperly consuming her antibiotics (drug, dose, frequency, duration unknown) which led to an overdose.Upon arrival at the emergency room the patient began having seizures and was transported to the intensive care unit, where she required intubation.On (b)(6) 2023 the patient was transitioned to hemodialysis (hd) due to her critical status, without reported issue.Over the next 15 days the patient¿s pd catheter (not a fresenius product) was removed, a permanent hd catheter (not a fresenius product) was placed, a percutaneous endoscopic gastrostomy (peg) tube (not a fresenius product) was inserted for nutrition and the patient underwent the placement of a tracheostomy tube (not a fresenius product).On (b)(6) 2023, the patient experienced a severe arterial rupture at the tracheotomy site and the bleeding could not be controlled.The patient¿s primary cause of death was hemorrhage from surgery.The pdrn stated the serious adverse events were unrelated to the patient¿s utilization of any fresenius device(s) and/or product(s).

Manufacturer Narrative

Upon review of mfr 2937457-2023-01173 there is no indication that the patient was in treatment when the adverse event occurred as the patient completed pd therapy more than 4 hours prior to the onset of the event.There was no reportable malfunction, serious injury, or death associated with the product reported in 2937457-2022-00585, therefore no further updates will be made on 2937457-2023-01173.

Event Description

On 4/aug/2023, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized.No additional information was provided during intake.During follow-up, the pd registered nurse (pdrn) confirmed the patient was hospitalized on (b)(6) 2023 after experiencing chest pain (occurred midday, completed dialysis >4 hours prior).The pdrn stated the patient was being treated for an ear infection and was improperly consuming her antibiotics (drug, dose, frequency, duration unknown) which led to an overdose.Upon arrival at the emergency room the patient began having seizures and was transported to the intensive care unit, where she required intubation.On (b)(6) 2023 the patient was transitioned to hemodialysis (hd) due to her critical status, without reported issue.Over the next 15 days the patient¿s pd catheter (not a fresenius product) was removed, a permanent hd catheter (not a fresenius product) was placed, a percutaneous endoscopic gastrostomy (peg) tube (not a fresenius product) was inserted for nutrition and the patient underwent the placement of a tracheostomy tube (not a fresenius product).On (b)(6) 2023, the patient experienced a severe arterial rupture at the tracheotomy site and the bleeding could not be controlled.The patient¿s primary cause of death was hemorrhage from surgery.The pdrn stated the serious adverse events were unrelated to the patient¿s utilization of any fresenius device(s) and/or product(s).

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.

• 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: 17497700
• MDR Text Key: 320769357
• Report Number: 0002937457-2023-01173
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2018
• 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): Required Intervention; Hospitalization; Death
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 84 KG