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 01/01/2020

Event Type  Injury  

Event Description

In a response to a customer experience survey, it was reported that a peritoneal dialysis (pd) patient had a hernia.The patient stated that they were on temporary hemodialysis but intended to returned to pd therapy after surgery.It is unknown if the patient was utilizing fresenius products while on pd modality.Attempts to obtain additional information could not be completed as there is no patient name or identifying demographics in which to follow-up.

Manufacturer Narrative

Clinical review: there is a possible temporal relationship between pd therapy utilizing the fresenius cycler and the patient event of hernia.However, it is unknown if this anonymous patient was utilizing fresenius product(s) at the time their reported hernia event occurred.Furthermore, there is no documentation in the complaint file to show a causal relationship between the hernia event and use of the fresenius cycler.Additionally, there is no allegation of a device malfunction or deficiency, or defect reported for the event.All patients on pd modality are at risk of hernia due to increased intra-abdominal pressure from the dialysate used during the normal physiological process of peritoneal dialysis therapy, as well as a weakened abdominal wall muscle made from an incision for placement of a pd catheter.Based on the limited information, with no allegation of a device malfunction, deficiency or defect and no confirmation that any fresenius product(s) were utilized, the fresenius cycler can be excluded as the cause of the patient¿s reported hernia event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

In a response to a customer experience survey, it was reported that a peritoneal dialysis (pd) patient had a hernia.The patient stated that they were on temporary hemodialysis but intended to returned to pd therapy after surgery.It is unknown if the patient was utilizing fresenius products while on pd modality.Attempts to obtain additional information could not be completed as there is no patient name or identifying demographics in which to follow-up.

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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13971982
• MDR Text Key: 289088321
• Report Number: 2937457-2022-00552
• 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: 04/12/2022

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: 04/02/2021
• Initial Date FDA Received: 03/31/2022
• Supplement Dates Manufacturer Received: 04/04/2022
• Supplement Dates FDA Received: 04/12/2022
• 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