MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY CYCLER UL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number UNKNOWN- LIBERTY CYCLER UL

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

Patient Problem Hernia (2240)

Event Date 01/01/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, through a clinic survey, fresenius became aware of this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on a fresenius cycler who experienced pain during the drain cycle of pd therapy due to a hernia.There was no specific allegation this adverse event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Multiple attempts were made to acquire further details concerning this patient¿s hernia and associated pain; however, no additional information was obtained.Patient demographics, type and cause of the patient¿s hernia, medical intervention required and any relationship to pd therapy or the use of any fresenius product(s) or device(s) remain unknown.In the intake, there was no indication the patient¿s hernia was related to the performance of any fresenius product(s) or device(s).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).Additionally; there is no allegation a fresenius product(s) or device(s) deficiency or malfunction caused or contributed to the patient¿s hernia.

Manufacturer Narrative

The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.Clinical investigation: it is unknown if a temporal relationship exists between ccpd therapy utilizing a fresenius cycler and the adverse event of the patient¿s hernia, characterized by pain during the drain cycle of pd therapy, as the date and timing of these events are unknown.It is well established for those patients undergoing pd therapy are at high risk for mechanical complication due to hernias of any etiology and may be safely repaired to continue successful pd therapy.In the absence of the required information, the cause of this patient¿s hernia cannot be determined, therefore, the fresenius cycler utilized for pd therapy cannot be excluded as a potential source or contributor to this patient¿s adverse events.Based on the available information, there was no allegation or objective evidence any fresenius product(s) or device(s) deficiency or malfunction caused or contributed to this patient¿s adverse event.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Investigation determines that there was no causal relationship between the objective evidence and the alleged event; the alleged event is unconfirmed.A product history review was not completed during the investigation as the serial number was not provided.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 8/oct/2021, through a clinic survey, fresenius became aware of this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on a fresenius cycler who experienced pain during the drain cycle of pd therapy due to a hernia.There was no specific allegation this adverse event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Multiple attempts were made to acquire further details concerning this patient¿s hernia and associated pain; however, no additional information was obtained.Patient demographics, type and cause of the patient¿s hernia, medical intervention required and any relationship to pd therapy or the use of any fresenius product(s) or device(s) remain unknown.In the intake, there was no indication the patient¿s hernia was related to the performance of any fresenius product(s) or device(s).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).Additionally, there is no allegation a fresenius product(s) or device(s) deficiency or malfunction caused or contributed to the patient¿s hernia.

• Brand Name: LIBERTY CYCLER UL
• 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: 15486222
• MDR Text Key: 300600330
• Report Number: 0002937457-2022-01554
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN- LIBERTY CYCLER UL
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: LIBERTY CYCLER SET; LIBERTY CYCLER SET; PD SOLUTION; PD SOLUTION
• Patient Outcome(s): Other