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

During a follow-up for a patient survey response, it was reported by a peritoneal dialysis registered nurse (pdrn) that this patient underwent a hernia repair (unknown date).The patient¿s pdrn reported this patient was diagnosed with an inguinal hernia which required surgical repair.The hernia was not pre-existing prior to the start of peritoneal dialysis (pd) therapy.After the surgery, the patient moved out of state.No further information was available as the patient¿s records were not available.

Manufacturer Narrative

Clinical review: there is a temporal relationship between pd therapy utilizing an unknown liberty cycler and the patient event of inguinal hernia requiring surgical repair and transition to hemodialysis.However, there is no documentation in the complaint file to show a causal relationship between the hernia and utilization of the liberty cycler.Although no information could be provided on the cause of the hernia, there is no allegation of a device malfunction or deficiency reported for the hernia event.Inguinal hernia is common in dialysis patients and caused by abdominal wall fragility and increased intra-abdominal pressure.Although it is unknown if pd therapy itself contributed to the hernia, there is no allegation of a device malfunction or deficiency or other fresenius product(s) causing the patient¿s hernia.Based on the available information and no allegation or evidence of a malfunction or deficiency, the liberty cycler can be excluded as the cause of the patient¿s inguinal hernia.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

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 a follow-up for a patient survey response, it was reported by a peritoneal dialysis registered nurse (pdrn) that this patient underwent a hernia repair (unknown date).The patient¿s pdrn reported this patient was diagnosed with an inguinal hernia which required surgical repair.The hernia was not pre-existing prior to the start of peritoneal dialysis (pd) therapy.After the surgery, the patient moved out of state.No further information was available as the patient¿s records were not available.

Manufacturer Narrative

Correction: the initial mfr report #: 2937457-2022-01676 was submitted with an inaccurate g.3.Date.The correct date is 9-23-2022.

Event Description

During a follow-up for a patient survey response, it was reported by a peritoneal dialysis registered nurse (pdrn) that this patient underwent a hernia repair (unknown date).The patient¿s pdrn reported this patient was diagnosed with an inguinal hernia which required surgical repair.The hernia was not pre-existing prior to the start of peritoneal dialysis (pd) therapy.After the surgery, the patient moved out of state.No further information was available as the patient¿s records were not available.

• 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: 15566047
• MDR Text Key: 301482145
• Report Number: 0002937457-2022-01676
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 12/11/2022
• 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 SELECT CYCLER
• Patient Outcome(s): Required Intervention
• Patient Sex: Female