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

Model Number	180111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A hospital registered nurse reported to fresenius technical services this hospitalized peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on a hospital provided liberty cycler (home cycler unknown) experienced an infection.There was no specific allegation this event was due to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Multiple attempts were made to acquire further details concerning this anonymous patient¿s infection; however, no additional information was obtained.In the intake, it was reported the patient was having drain complications during ccpd therapy on the hospital provided liberty cycler due to this reported infection; however, there was no indication the infection was related to the performance of any fresenius product(s) or device(s).
Additional Manufacturer Narrative
Clinical review: presently there is no allegation or objective evidence indicating a serious injury, patient death, or other adverse event(s) occurred related to a fresenius product(s) or device(s) warranting further investigation.Additionally, there is no allegation a fresenius product(s) or device(s) deficiency or malfunction caused or contributed to the patient¿s infection.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional 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 or Problem Description
A hospital registered nurse reported to fresenius technical services this hospitalized peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on a hospital provided liberty cycler (home cycler unknown) experienced an infection.There was no specific allegation this event was due to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Multiple attempts were made to acquire further details concerning this anonymous patient¿s infection; however, no additional information was obtained.In the intake, it was reported the patient was having drain complications during ccpd therapy on the hospital provided liberty cycler due to this reported infection; however, there was no indication the infection was related to the performance of any fresenius product(s) or device(s).
Event or Problem Description
A hospital registered nurse reported to fresenius technical services this hospitalized peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on a hospital provided liberty cycler (home cycler unknown) experienced an infection.There was no specific allegation this event was due to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Multiple attempts were made to acquire further details concerning this anonymous patient¿s infection; however, no additional information was obtained.In the intake, it was reported the patient was having drain complications during ccpd therapy on the hospital provided liberty cycler due to this reported infection; however, there was no indication the infection was related to the performance of any fresenius product(s) or device(s).
Additional Manufacturer Narrative
Plant investigation: the actual device was returned to the manufacturer for physical evaluation.A visual inspection of the returned cycler exterior showed no sign of physical damage.There were visual indications of dried fluid within the cassette compartment.There were no visual indication of particulates within the cassette area.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.An as received simulated treatment with reduced dwell times was performed and completed without any failures or problems.The cycler weighed fill volume values were within tolerance for a liberty cycler.The system air leak test passed.The valve actuation test passed.The teach pump test passed.There were visual indications of dried fluid under pump ¿a¿ and ¿b¿ mushroom head and within the recess of the bottom cover adjacent to the pump assembly.The cause of the observed dried fluid and fluid could not be determined.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.

• Brand Name: UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED)
• Common Device Name: 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: 15219321
• Report Number: 0002937457-2022-01349
• Device Sequence Number: 15112230
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 180111
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2022
• Supplement Date Received by Manufacturer: 08/19/2022; 07/13/2023
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 08/30/2022; 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown