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 Pain (1994); Hernia (2240); Swelling/ Edema (4577)

Event Date 01/27/2023

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: a temporal relationship exists between pd therapy with the liberty select cycler and the patient¿s inguinal hernia (characterized by swelling and pain) which required subsequent repair.Hernia is a well-documented complication in pd patient¿s due to an expected increased intra-abdominal pressure from the dialysate during pd treatment.Moreover, the patient has chronic constipation which is a risk factor for hernia development due to increased intra-abdominal pressure with difficulty moving bowels.Nonetheless, the concomitant use of the fresenius cycler to facilitate dialysis cannot be excluded as a contributory factor in the event.However, currently there is no reported allegation or objective evidence that a liberty select cycler malfunction or product deficiency caused serious harm to the patient.

Event Description

On (b)(6) 2023, this patient on peritoneal dialysis (pd) reported he previously had hernia surgery during a call to customer support for a drain complication during pd treatment with the fresenius cycler.Therefore, more follow-up was performed with the patient¿s pd nurse.It was reported that the patient began pd therapy in (b)(6) of 2021 and began using the fresenius cycler in (b)(6) of 2021.Per the nurse, the patient has an inguinal hernia which is not believed to be a pre-existing condition.The nurse stated the patient was having symptoms of pain and swelling.Subsequently, on (b)(6) 2023, the patient underwent repair of the inguinal hernia and subsequently continues pd treatment with the same cycler.The nurse confirmed the patient has not had any cycler malfunctions or overfill events related to the hernia.While the exact cause of the hernia is unknown; the nurse stated the patient has chronic constipation which is a risk factor for hernia development due to straining.Moreover, the chronic constipation is suspected to be causing intermittent and positional drain issues from the pd catheter (not a fresenius product) during pd treatment with the fresenius cycler.

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) 2023, this patient on peritoneal dialysis (pd) reported he previously had hernia surgery during a call to customer support for a drain complication during pd treatment with the fresenius cycler.Therefore, more follow-up was performed with the patient¿s pd nurse.It was reported that the patient began pd therapy in (b)(6) 2021 and began using the fresenius cycler in (b)(6) 2021.Per the nurse, the patient has an inguinal hernia which is not believed to be a pre-existing condition.The nurse stated the patient was having symptoms of pain and swelling.Subsequently, on (b)(6) 2023, the patient underwent repair of the inguinal hernia and subsequently continues pd treatment with the same cycler.The nurse confirmed the patient has not had any cycler malfunctions or overfill events related to the hernia.While the exact cause of the hernia is unknown; the nurse stated the patient has chronic constipation which is a risk factor for hernia development due to straining.Moreover, the chronic constipation is suspected to be causing intermittent and positional drain issues from the pd catheter (not a fresenius product) during pd treatment with the fresenius cycler.

• 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: 16327864
• MDR Text Key: 309084999
• Report Number: 0002937457-2023-00183
• 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: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2018
• 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: 80 YR
• Patient Sex: Male