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 Pain (1994); Urinary Tract Infection (2120)

Event Date 04/20/2023

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: based on the available information, the patient¿s liberty select cycler is disassociated from the events.There is no allegation or objective evidence indicating a serious injury, patient death, or other serious adverse event(s) related to a fresenius device(s) and/or product(s) occurred warranting further investigation.Furthermore, there was no report a fresenius device(s) and/or product(s) failed to meet user expectations or manufacturer specifications.

Event Description

On (b)(6) 2023, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) emergently disconnected ccpd therapy due to pain on (b)(6) 2023.Follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient presented to the emergency room on the morning of (b)(6) 2023 with complaints of groin pain.An analysis of the patient¿s urine revealed the patient had a significant urinary tract infection.The patient was given a single dose of an intravenous antibiotic (drug, dose not provided), and was released later the same day with a prescription for oral ciprofloxacin daily (dose, duration not provided).The pdrn reported the events were unrelated to any fresenius product(s) and/or device(s).The patient continues to undergo ccpd therapy utilizing the same liberty select cycler and is recovering (pain resolved) from the adverse events.

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 20/apr/2023, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) emergently disconnected ccpd therapy due to pain on (b)(6) 2023.Follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient presented to the emergency room on the morning of (b)(6) 2023 with complaints of groin pain.An analysis of the patient¿s urine revealed the patient had a significant urinary tract infection.The patient was given a single dose of an intravenous antibiotic (drug, dose not provided), and was released later the same day with a prescription for oral ciprofloxacin daily (dose, duration not provided).The pdrn reported the events were unrelated to any fresenius product(s) and/or device(s).The patient continues to undergo ccpd therapy utilizing the same liberty select cycler and is recovering (pain resolved) from the adverse events.

• 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: 16806787
• MDR Text Key: 313917494
• Report Number: 0002937457-2023-00605
• 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: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• 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?: No
• Device Age: MO
• Date Manufacturer Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female