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 Problem Hernia (2240)

Event Date 03/22/2019

Event Type  Injury  

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 (b)(6) 2019, this (b)(6)-year-old female patient on peritoneal dialysis (pd) contacted fresenius and reported she was concerned about a negative ultrafiltration (uf) of 35 in cycle 2 of a previous pd treatment on (b)(6) 2019.At the time of the call, there were no reported liberty select cycler product deficiencies or malfunctions or any reported serious adverse events.A review of the treatment data captured revealed the patient bypassed out of drain 0 and proceeded to fill with 501cc of pd solution (1.5% delflex) in cycle 1.The patient reportedly does not perform a last fill that would have been expected in drain 0.The patient subsequently drained 465 out (out of 501 expected) which resulted in a -35 uf.The patient did not fill again in cycle 2 (per the recorded treatment data) and the cycler powered off.The nurse stated the patient likely turned the cycler off.The patient completed their pd treatment manually without any reported serious injuries.There was no indication of increased intra-peritoneal volume (iipv) event.During follow-up, it was discovered the patient was experiencing distention in her hernia during this event.Per the nurse, the hernia was pre-existing which reportedly developed and required two repairs prior to start of pd therapy.Per the patient¿s nurse, upon initiation of pd therapy the surgeon stated the hernia could not be repaired any further.The nurse stated the patient has very low fill volumes for dialysis and the patient is also very thin- approximately (b)(6) pounds.Reportedly, the patient is non-compliant with pd treatment; completing only 2 out of every 10 dialysis treatments.The nurse stated that the patient does experience distention and discomfort in her hernia with pd solution in her.However, the nurse confirmed the hernia has not worsened due to pd therapy and the patient has not required any medical intervention for the issue.Due to the patient¿s discomfort and non-compliance with pd treatments, the patient is considering transitioning to hemodialysis modality as these confounding factors make the patient a poor candidate for pd therapy.Currently, the patient reportedly continues pd treatments with the same cycler without further issue.Based on the available information there is no objective evidence that the liberty select cycler caused or contributed to a serious adverse patient outcome.The reported hernia was pre-existing and reportedly did not worsen with pd therapy or require any medical intervention.Additionally, while it was reported the patient experiences distension and discomfort with pd solution; there were no reports of any medical intervention required for this issue.Additionally, there is no evidence of a reportable iipv event with the data provided.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: matthew amaral ; 920 winter st.; waltham, MA 02451 ; 7816999758
• MDR Report Key: 8554401
• MDR Text Key: 143227215
• Report Number: 2937457-2019-01211
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 04/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2010
• 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; LIBERTY CYCLER SET
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 32