MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180343

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

Patient Problem Hernia (2240)

Event Date 01/11/2024

Event Type  Injury  

Event Description

It was reported that this peritoneal dialysis (pd) patient was recovering from hernia surgery.Additional information was obtained from the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was diagnosed with an umbilical and an inguinal hernia on an unknown date.The hernias were not pre-existing prior to the initiation of pd therapy as the surgeon who placed the pd catheter stated the hernias were not there at the time of placement.The patient underwent hernia repair in an outpatient procedure on (b)(6) 2024.The patient completed in-center hemodialysis (hd) for three weeks during recovery.The patient has since returned to pd therapy with a gradual increase in fill volume to 1,500ml.The physician authorized the patient to return to his regular treatments as of 26/feb/2024.The patient completed four exchanges with no last fill or daytime exchange.The patient does have urine function.The patient did not require any pd prescription changes prior to the hernia repair.The cause of the hernias could not be determined.

Manufacturer Narrative

Clinical review: there is a potential temporal relationship between pd therapy utilizing the liberty select cycler and the patient event of umbilical and inguinal hernia with surgical repair as the hernias were diagnosed after the initiation of pd therapy, but it is unknown how or when the hernias occurred.However, there is no documentation in the complaint file to show a causal relationship between the hernias and use of the liberty select cycler.Additionally, there is no allegation of a device malfunction or deficiency reported for the event.The cause of the hernias are not known.Patients on pd therapy are at risk of developing a hernia for several reasons including increased stress on the muscles of the abdomen which can be a result of the opening in the abdominal muscle created by the pd catheter.Pd therapy did not exacerbate any symptoms for the patient and no alterations were made to the patient¿s pd prescription prior to the hernia repair.Based on the available information and no allegation or evidence of a malfunction or deficiency related to the hernias, the liberty select cycler can be excluded as the cause of the hernias.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported that this peritoneal dialysis (pd) patient was recovering from hernia surgery.Additional information was obtained from the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was diagnosed with an umbilical and an inguinal hernia on an unknown date.The hernias were not pre-existing prior to the initiation of pd therapy as the surgeon who placed the pd catheter stated the hernias were not there at the time of placement.The patient underwent hernia repair in an outpatient procedure on (b)(6) 2024.The patient completed in-center hemodialysis (hd) for three weeks during recovery.The patient has since returned to pd therapy with a gradual increase in fill volume to 1,500ml.The physician authorized the patient to return to his regular treatments as of (b)(6) 2024.The patient completed four exchanges with no last fill or daytime exchange.The patient does have urine function.The patient did not require any pd prescription changes prior to the hernia repair.The cause of the hernias could not be determined.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.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.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• 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: 18839435
• MDR Text Key: 336959250
• Report Number: 0002937457-2024-00388
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222318
• 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
• Report Date: 03/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2013
• 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