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 08/01/2020

Event Type  Injury  

Event Description

It was reported to fresenius (via a customer experience survey) that this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was diagnosed with a hernia.No additional information was provided during intake.Follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient underwent the surgical repair of a ventral hernia.During the repair, it was determined the patient¿s ventral hernia was too large and was unable to be repaired in a manner consistent with continuing pd therapy.Therefore, the patient¿s pd catheter (not a fresenius product) was removed, and a hemodialysis (hd) catheter (not a fresenius product) was surgically placed.The pdrn reported the patient¿s ventral hernia formed since the patient had begun pd therapy but could not point to any specific incident/event.The patient has recovered from the events and is tolerating incenter hd without issue.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: a temporal relationship exists between ccpd therapy utilizing the liberty cycler, and the patient¿s serious adverse events of a ventral hernia, which warranted surgical intervention.While there is no allegation or objective evidence indicating a fresenius product(s) and/or device(s) deficiency or malfunction caused the event(s) the liberty cycler cannot be excluded from having a possible causal and/or contributory role in the creation and/or exacerbation of the patient¿s ventral hernia, as it was undiagnosed when the patient began pd for rrt.Hernias are a well-known potential complication of pd therapy due to increased intra-abdominal pressure created during pd therapy.During therapy, this pressure caused can create or exacerbate weaknesses in the supporting abdominal wall structures.Additionally, the surgical introduction of a pd catheter (not a fresenius product) also increases the risk of hernia formation.

Event Description

It was reported to fresenius (via a customer experience survey) that this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was diagnosed with a hernia.No additional information was provided during intake.Follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient underwent the surgical repair of a ventral hernia.During the repair, it was determined the patient¿s ventral hernia was too large and was unable to be repaired in a manner consistent with continuing pd therapy.Therefore, the patient¿s pd catheter (not a fresenius product) was removed, and a hemodialysis (hd) catheter (not a fresenius product) was surgically placed.The pdrn reported the patient¿s ventral hernia formed since the patient had begun pd therapy but could not point to any specific incident/event.The patient has recovered from the events and is tolerating incenter hd without issue.

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.As a serial number could not be determined, device history and manufacturing records could not be reviewed.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

• 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: 15502742
• MDR Text Key: 300765592
• Report Number: 0002937457-2022-01586
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN- LIBERTY CYCLER UL
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 09/29/2022
• Supplement Dates Manufacturer Received: 09/29/2022
• Supplement Dates FDA Received: 09/30/2022
• 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: DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male