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 Problem Hernia (2240)

Event Date 01/01/2021

Event Type  Injury  

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 drain complications), which warranted 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.Despite the patient¿s report of a construction incident causing the hernia (4 years ago, specifics not provided), there is no objective evidence or clinical confirmation the patient¿s statements are accurate.Therefore, the liberty select cycler cannot be disassociated from the serious adverse events.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.

Event Description

A patient with end stage renal disease (esrd) on continuous cyclic pd (ccpd) therapy for renal replacement therapy (rrt) reported recently having undergone a hernia surgery.Follow-up with the patient confirmed he was diagnosed with an umbilical hernia, which likely developed four years prior to beginning pd therapy (2.5 years ago) after an incident at the construction site (specifics not provided).Approximately 3 months ago, the patient reported undergoing the surgical repair of the umbilical hernia, while simultaneously receiving a replacement pd catheter (not a fresenius product) due to mal-positioning (bent).The patient reported he never experienced any pain and/or ¿aggravation¿ of the umbilical hernia because of ccpd therapy, nor were any orders adjusted due to the umbilical hernia¿s presence.The patient indicated he does not attribute causality to the use of a fresenius device(s) and/or product(s).After the umbilical hernia repair was completed, the patient continued with ccpd therapy, utilizing the same liberty select cycler as before the event(s).The cycler is not available to be returned for manufacturing analysis.

Event Description

A patient with end stage renal disease (esrd) on continuous cyclic pd (ccpd) therapy for renal replacement therapy (rrt) reported recently having undergone a hernia surgery.Follow-up with the patient confirmed he was diagnosed with an umbilical hernia, which likely developed four years prior to beginning pd therapy (2.5 years ago) after an incident at the construction site (specifics not provided).Approximately 3 months ago, the patient reported undergoing the surgical repair of the umbilical hernia, while simultaneously receiving a replacement pd catheter (not a fresenius product) due to mal-positioning (bent).The patient reported he never experienced any pain and/or ¿aggravation¿ of the umbilical hernia because of ccpd therapy, nor were any orders adjusted due to the umbilical hernia¿s presence.The patient indicated he does not attribute causality to the use of a fresenius device(s) and/or product(s).After the umbilical hernia repair was completed, the patient continued with ccpd therapy, utilizing the same liberty select cycler as before the event(s).The cycler is not available to be returned for manufacturing analysis.

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 patient with end stage renal disease (esrd) on continuous cyclic pd (ccpd) therapy for renal replacement therapy (rrt) reported recently having undergone a hernia surgery.Follow-up with the patient confirmed he was diagnosed with an umbilical hernia, which likely developed four years prior to beginning pd therapy (2.5 years ago) after an incident at the construction site (specifics not provided).Approximately 3 months ago, the patient reported undergoing the surgical repair of the umbilical hernia, while simultaneously receiving a replacement pd catheter (not a fresenius product) due to mal-positioning (bent).The patient reported he never experienced any pain and/or ¿aggravation¿ of the umbilical hernia because of ccpd therapy, nor were any orders adjusted due to the umbilical hernia¿s presence.The patient indicated he does not attribute causality to the use of a fresenius device(s) and/or product(s).After the umbilical hernia repair was completed, the patient continued with ccpd therapy, utilizing the same liberty select cycler as before the event(s).The cycler is not available to be returned for manufacturing analysis.

Event Description

A patient with end stage renal disease (esrd) on continuous cyclic pd (ccpd) therapy for renal replacement therapy (rrt) reported recently having undergone a hernia surgery.Follow-up with the patient confirmed he was diagnosed with an umbilical hernia, which likely developed four years prior to beginning pd therapy (2.5 years ago) after an incident at the construction site (specifics not provided).Approximately 3 months ago, the patient reported undergoing the surgical repair of the umbilical hernia, while simultaneously receiving a replacement pd catheter (not a fresenius product) due to mal-positioning (bent).The patient reported he never experienced any pain and/or ¿aggravation¿ of the umbilical hernia because of ccpd therapy, nor were any orders adjusted due to the umbilical hernia¿s presence.The patient indicated he does not attribute causality to the use of a fresenius device(s) and/or product(s).After the umbilical hernia repair was completed, the patient continued with ccpd therapy, utilizing the same liberty select cycler as before the event(s).The cycler is not available to be returned for manufacturing analysis.

Manufacturer Narrative

Additional information: d.9., h.3.Plant investigation: the actual device was returned to the manufacturer for physical evaluation.A visual inspection of the returned cycler exterior showed no sign of physical damage.There were visual indications of dried fluid encountered within the cassette compartment.There were visual indication of particulates around the catch post area and within cassette compartment.There were no burrs or sharp edges in the cassette area that may have punctured a cassette membrane.Function/display test passed.Valve actuation test passed.System air leak test passed.An (as-received) 11000 ml simulated treatment was performed and completed without failures.There were visual indications of dried fluid found in between of the pump assembly and front panel assembly during internal inspection.There were visual indications of dried fluid within the recess of the bottom cover adjacent to the pump during internal inspection.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.

• 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: 12895055
• MDR Text Key: 281421524
• Report Number: 2937457-2021-02359
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• 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?: Device Returned to Manufacturer
• Device Age: MO
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2021
• 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; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 84 KG