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

Model Number 180343

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

Patient Problems Abdominal Pain (1685); Hernia (2240)

Event Date 11/01/2021

Event Type  Injury  

Manufacturer Narrative

Clinical review: a temporal relationship exists between pd therapy with the liberty select cycler and the patient¿s hernia.Hernia is a well-documented potential complication in pd patient¿s due to an expected increased intra-abdominal pressure from the dialysate during pd treatment.The increased intra-abdominal pressure can exacerbate any potentially pre-existing muscle weakness that causes hernia formation.At this time, it cannot be distinguished if the hernia was pre-existing prior to the start of pd therapy.However, the nurse reported the hernia was suspected to have been pre-existing.The patient reportedly experienced abdominal pain while on pd therapy which ultimately led to outpatient repair of the hernia.Therefore, the concomitant use of the device to facilitate dialysis needs is a likely contributory factor.Currently, there have been no reported allegations that a fresenius cycler malfunction nor any overfill events were related to this hernia event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A peritoneal dialysis (pd) patient 's contact reported a drain slowly message.During follow-up call for the reported issue, the home therapy program manager (htpm) stated the patient previously had hernia repair and pd catheter (not a fresenius product) manipulation.In addition, it was reported the patient is undergoing further pd catheter (not a fresenius product) evaluation for blood in the catheter from recent surgery.In a subsequent call, the patient¿s pd nurse confirmed that the patient underwent an outpatient hernia repair approximately 1 month ago (date unknown).The pd nurse was not able to provide the location of the patient¿s hernia but indicated the hernia is suspected to have been pre-existing prior to pd therapy.Per the nurse, the patient was experiencing abdominal pain intermittently.As a result, the patient underwent the hernia repair but since has had blood in the pd catheter.It was reported the patient is recovering from the hernia surgery and continues pd with the same cycler and manual pd exchanges.However, the nurse stated that scar tissue may be affecting draining from the pd catheter.As a result, the patient¿s pd catheter is being evaluated as it is reportedly not working properly.The nurse confirmed the patient has not had any adverse effects from use of any fresenius device, or product.Additionally, the nurse provided there were no cycler malfunctions, nor any overfill events related to this hernia event.Rather, it was stated the patient¿s abdominal pain (which led to hernia repair) was likely due to normal physiology of pd therapy in the setting of a pre-existing hernia.The cycler is not available to be returned for manufacturer to investigate.

Event Description

A peritoneal dialysis (pd) patient 's contact reported a drain slowly message.During follow-up call for the reported issue, the home therapy program manager (htpm) stated the patient previously had hernia repair and pd catheter (not a fresenius product) manipulation.In addition, it was reported the patient is undergoing further pd catheter (not a fresenius product) evaluation for blood in the catheter from recent surgery.In a subsequent call, the patient¿s pd nurse confirmed that the patient underwent an outpatient hernia repair approximately 1 month ago (date unknown).The pd nurse was not able to provide the location of the patient¿s hernia but indicated the hernia is suspected to have been pre-existing prior to pd therapy.Per the nurse, the patient was experiencing abdominal pain intermittently.As a result, the patient underwent the hernia repair but since has had blood in the pd catheter.It was reported the patient is recovering from the hernia surgery and continues pd with the same cycler and manual pd exchanges.However, the nurse stated that scar tissue may be affecting draining from the pd catheter.As a result, the patient¿s pd catheter is being evaluated as it is reportedly not working properly.The nurse confirmed the patient has not had any adverse effects from use of any fresenius device, or product.Additionally, the nurse provided there were no cycler malfunctions, nor any overfill events related to this hernia event.Rather, it was stated the patient¿s abdominal pain (which led to hernia repair) was likely due to normal physiology of pd therapy in the setting of a pre-existing hernia.The cycler is not available to be returned for manufacturer to investigate.

Manufacturer Narrative

Additional information: h.3.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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13145649
• MDR Text Key: 284177018
• Report Number: 2937457-2022-00007
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2009
• 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: 72 YR
• Patient Sex: Male