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 10/01/2021

Event Type  Injury  

Event Description

A peritoneal dialysis registered nurse (pdrn) reported that a patient was diagnosed with an umbilical hernia, however it is unknown if it was present prior to the patient beginning pd for renal replacement therapy (rrt).The pdrn reported the patient was experiencing frequent drain complications, as well as abdominal pain.The patient¿s peritoneal effluent fluid cultures were negative, so the nephrologist ordered radiological studies (specifics not provided) of the abdomen, which diagnosed the umbilical hernia.The patient was scheduled to undergo a surgical hernia repair on (b)(6) 2021, however the patient missed the required presurgical cardiac testing and the surgery was postponed.Per the pdrn, the etiology of the hernia is unknown, but was not caused by a liberty select cycler malfunction.The pdrn stated the patient has resumed continuous cyclic pd (ccpd) utilizing the same liberty select cycler as before until the surgery can be rescheduled.The cycler is not available to return for evaluation.

Manufacturer Narrative

Clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, and the patient¿s serious adverse events of an umbilical hernia (characterized by abdominal pain and drain complications), which warrants surgical intervention.While there is no allegation or objective evidence indicating a fresenius product(s) or device(s) deficiency or malfunction caused the event(s).The liberty select cycler cannot be excluded from having a possible causal and/or contributory role in the creation and/or exacerbation of the patient¿s umbilical hernia, as it was undiagnosed when the patient began rrt.Hernias are a well-known potential complication of pd therapy due to increased intra-abdominal pressure created during pd therapy.During therapy, this pressure caused can create or exacerbate weaknesses in the supporting abdominal wall structures.Additionally, the surgical introduction of the pd catheter (not a fresenius product) also increases the risk of hernia formation.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Manufacturer Narrative

Additional information: g.1.Corrected information: b.2., h.6.

Event Description

A peritoneal dialysis registered nurse (pdrn) reported that a patient was diagnosed with an umbilical hernia, however it is unknown if it was present prior to the patient beginning pd for renal replacement therapy (rrt).The pdrn reported the patient was experiencing frequent drain complications, as well as abdominal pain.The patient¿s peritoneal effluent fluid cultures were negative, so the nephrologist ordered radiological studies (specifics not provided) of the abdomen, which diagnosed the umbilical hernia.The patient was scheduled to undergo a surgical hernia repair on (b)(6) 2021, however the patient missed the required presurgical cardiac testing and the surgery was postponed.Per the pdrn, the etiology of the hernia is unknown, but was not caused by a liberty select cycler malfunction.The pdrn stated the patient has resumed continuous cyclic pd (ccpd) utilizing the same liberty select cycler as before until the surgery can be rescheduled.The cycler is not available to return for evaluation.

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.

Event Description

A peritoneal dialysis registered nurse (pdrn) reported that a patient was diagnosed with an umbilical hernia, however it is unknown if it was present prior to the patient beginning pd for renal replacement therapy (rrt).The pdrn reported the patient was experiencing frequent drain complications, as well as abdominal pain.The patient¿s peritoneal effluent fluid cultures were negative, so the nephrologist ordered radiological studies (specifics not provided) of the abdomen, which diagnosed the umbilical hernia.The patient was scheduled to undergo a surgical hernia repair on (b)(6) 2021, however the patient missed the required presurgical cardiac testing and the surgery was postponed.Per the pdrn, the etiology of the hernia is unknown, but was not caused by a liberty select cycler malfunction.The pdrn stated the patient has resumed continuous cyclic pd (ccpd) utilizing the same liberty select cycler as before until the surgery can be rescheduled.The cycler is not available to return for evaluation.

• 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: 12772812
• MDR Text Key: 282714644
• Report Number: 2937457-2021-02246
• 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: K181108
• 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: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• 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: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2013
• 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; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male