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 06/01/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 a contact for this female peritoneal dialysis (pd) patient called fresenius technical support to request assistance with adjusting the patient¿s last fill volume from 1,000ml to 0ml.The caller stated this was per the surgeon as the patient just had surgery.Upon follow-up, the patient reported having had hernia repair surgery on (b)(6) 2022.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was diagnosed with a ventral hernia on an unknown date.The surgeon determined that no intervention was necessary unless the patient began having symptoms.The patient was followed for several months prior to experiencing abdominal pain (date unknown).The surgeon had an opening for the hernia repair.The patient underwent a hernia repair surgery on (b)(6) 2022.The patient refused to complete dialysis treatment during the hospitalization.Per documentation from a separate event, the patient was hypoxic during the hospitalization and discharged on 2l of oxygen.The patient has a significant history of tobacco use.The patient was discharged to home on (b)(6) 2022.The patient has a history of polycystic kidney disease (pkd) and is prone to hernias.The cause of this hernia is attributed to the pkd.The patient was unable to complete pd therapy upon discharge due to a pd catheter (not a fresenius product) malfunction but the issue has since resolved and is continuing to complete dialysis utilizing the liberty select cycler.No further information was provided.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: there is a temporal relationship between pd therapy utilizing the liberty select cycler and the patient event of ventral hernia.However, there is no documentation in the complaint file to show a causal relationship between the hernia and utilization of the liberty select cycler.Additionally, there is no allegation of a device malfunction or deficiency reported for the hernia event.Per the pdrn, the patient has polycystic kidney disease putting the patient at increased risk for hernia development and this has been attributed as the cause of the hernia.Episodes of abdominal hernia appeared statistically more often in pkd patients treated with pd; however, abdominal wall complications have been found to be more frequent in pkd patients at all stages of kidney disease including before end stage renal disease.Based on the available information and no allegation of a malfunction or deficiency, the liberty select cycler can be excluded as the cause of the patient¿s ventral hernia.

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

On (b)(6) 2022 a contact for this female peritoneal dialysis (pd) patient called fresenius technical support to request assistance with adjusting the patient¿s last fill volume from 1,000ml to 0ml.The caller stated this was per the surgeon as the patient just had surgery.Upon follow-up, the patient reported having had hernia repair surgery on 01/jun/2022.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was diagnosed with a ventral hernia on an unknown date.The surgeon determined that no intervention was necessary unless the patient began having symptoms.The patient was followed for several months prior to experiencing abdominal pain (date unknown).The surgeon had an opening for the hernia repair.The patient underwent a hernia repair surgery on 01/jun/2022.The patient refused to complete dialysis treatment during the hospitalization.Per documentation from a separate event, the patient was hypoxic during the hospitalization and discharged on 2l of oxygen.The patient has a significant history of tobacco use.The patient was discharged to home on (b)(6) 2022.The patient has a history of polycystic kidney disease (pkd) and is prone to hernias.The cause of this hernia is attributed to the pkd.The patient was unable to complete pd therapy upon discharge due to a pd catheter (not a fresenius product) malfunction but the issue has since resolved and is continuing to complete dialysis utilizing the liberty select cycler.No further information was provided.

• 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: 14789562
• MDR Text Key: 294834950
• Report Number: 0002937457-2022-01022
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• 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
• Device Age: MO
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2015
• 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; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 73 KG