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

During follow up for an anonymous customer experience survey, the peritoneal dialysis nurse (pdrn) reported remembering the patient¿s inguinal hernia was diagnosed prior to beginning pd therapy.The pdrn also remembered the patient¿s hernia ruptured, however they were unable to recall the specifics surrounding causality (occurred sometime in 2020).The patient reportedly underwent the surgical repair of the inguinal hernia, as well as the placement of a permanent hemodialysis (hd) catheter (not a fresenius product).The patient was permanently transitioned to hd for renal replacement therapy (rrt) due to the damage sustained when the hernia ruptured.The patient has recovered from the events and continues to undergo incenter hd without issue.The pdrn could not recall any additional details, and he was unable to access the patient¿s records.It is unknown if pd therapy was continued in the hospital or if any fresenius device(s) or product(s) were utilized during hospitalization.Additional details surrounding the patient¿s hospital course and condition were requested, however, not provided.

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 an unknown liberty select cycler, and the serious adverse event(s) of an inguinal hernia.The definitive cause of the patient¿s ruptured hernia is unknown; therefore, causality cannot firmly be established.While there is no allegation or objective evidence indicating a fresenius product(s) and/or device(s) deficiency or malfunction occurred, the unknown cycler cannot be excluded from having a possible causal and/or contributory role in the exacerbation of the patient¿s preexisting inguinal hernia.Limited follow-up information precluded a more comprehensive investigation.Hernias are a well-known potential complication of pd therapy due to the increased intra-abdominal pressure created during treatment.During treatment, this increased intraabdominal pressure can cause and/or exacerbate weaknesses in the supporting abdominal wall structures leading in this case to a rupture.

Event Description

During follow up for an anonymous customer experience survey, the peritoneal dialysis nurse (pdrn) reported remembering the patient¿s inguinal hernia was diagnosed prior to beginning pd therapy.The pdrn also remembered the patient¿s hernia ruptured, however they were unable to recall the specifics surrounding causality (occurred sometime in 2020).The patient reportedly underwent the surgical repair of the inguinal hernia, as well as the placement of a permanent hemodialysis (hd) catheter (not a fresenius product).The patient was permanently transitioned to hd for renal replacement therapy (rrt) due to the damage sustained when the hernia ruptured.The patient has recovered from the events and continues to undergo incenter hd without issue.The pdrn could not recall any additional details, and he was unable to access the patient¿s records.It is unknown if pd therapy was continued in the hospital or if any fresenius device(s) or product(s) were utilized during hospitalization.Additional details surrounding the patient¿s hospital course and condition were requested, however, not provided.

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.

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.

Event Description

During follow up for an anonymous customer experience survey, the peritoneal dialysis nurse (pdrn) reported remembering the patient¿s inguinal hernia was diagnosed prior to beginning pd therapy.The pdrn also remembered the patient¿s hernia ruptured, however they were unable to recall the specifics surrounding causality (occurred sometime in 2020).The patient reportedly underwent the surgical repair of the inguinal hernia, as well as the placement of a permanent hemodialysis (hd) catheter (not a fresenius product).The patient was permanently transitioned to hd for renal replacement therapy (rrt) due to the damage sustained when the hernia ruptured.The patient has recovered from the events and continues to undergo incenter hd without issue.The pdrn could not recall any additional details, and he was unable to access the patient¿s records.It is unknown if pd therapy was continued in the hospital or if any fresenius device(s) or product(s) were utilized during hospitalization.Additional details surrounding the patient¿s hospital course and condition were requested, however, not provided.

• 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: 15457729
• MDR Text Key: 300273000
• Report Number: 0002937457-2022-01530
• 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,Followup
• Report Date: 11/17/2022

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: 09/06/2022
• Initial Date FDA Received: 09/20/2022
• Supplement Dates Manufacturer Received: 10/25/2022; 11/16/2022
• Supplement Dates FDA Received: 10/27/2022; 11/17/2022
• 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; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female