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 04/19/2022

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 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) and/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 a pd catheter (not a fresenius product) also increases the risk of hernia formation.

Event Description

On 28/apr/2022, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) underwent hernia surgery (date not provided).Follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient was diagnosed with an umbilical hernia, which was not present prior to the patient beginning pd for rrt.The pdrn reported the patient was experiencing frequent drain complications.On (b)(6) 2022, the patient successfully underwent an outpatient umbilical hernia repair, and was released from the hospital in stable condition later the same day.Per the pdrn, no fresenius product(s) and/or device(s) deficiency or malfunction occurred; however, the patient¿s umbilical hernia developed since he began pd therapy for rrt.As of (b)(6) 2022, the patient¿s alzheimer¿s had worsened, and he has become combative.The patient¿s spouse is elderly and cannot continue caring for her spouse.As such, the patient will be transitioned to hemodialysis (hd) in the next week, after receiving an hd dialysis catheter (not a fresenius product).The patient will then transition to an outpatient hd clinic for rrt.

Event Description

On (b)(6) 2022, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) underwent hernia surgery (date not provided).Follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient was diagnosed with an umbilical hernia, which was not present prior to the patient beginning pd for rrt.The pdrn reported the patient was experiencing frequent drain complications.On (b)(6) 2022, the patient successfully underwent an outpatient umbilical hernia repair, and was released from the hospital in stable condition later the same day.Per the pdrn, no fresenius product(s) and/or device(s) deficiency or malfunction occurred; however, the patient¿s umbilical hernia developed since he began pd therapy for rrt.As of (b)(6) 2022, the patient¿s alzheimer¿s had worsened, and he has become combative.The patient¿s spouse is elderly and cannot continue caring for her spouse.As such, the patient will be transitioned to hemodialysis (hd) in the next week, after receiving an hd dialysis catheter (not a fresenius product).The patient will then transition to an outpatient hd clinic for rrt.

Manufacturer Narrative

Corrected information provided in b3, e3, d10, and g2.

Event Description

On 28/apr/2022, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) underwent hernia surgery (date not provided).Follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient was diagnosed with an umbilical hernia, which was not present prior to the patient beginning pd for rrt.The pdrn reported the patient was experiencing frequent drain complications.On (b)(6) 2022, the patient successfully underwent an outpatient umbilical hernia repair, and was released from the hospital in stable condition later the same day.Per the pdrn, no fresenius product(s) and/or device(s) deficiency or malfunction occurred; however, the patient¿s umbilical hernia developed since he began pd therapy for rrt.As of (b)(6) 2022, the patient¿s alzheimer¿s had worsened, and he has become combative.The patient¿s spouse is elderly and cannot continue caring for her spouse.As such, the patient will be transitioned to hemodialysis (hd) in the next week, after receiving an hd dialysis catheter (not a fresenius product).The patient will then transition to an outpatient hd clinic for rrt.

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 28/apr/2022, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) underwent hernia surgery (date not provided).Follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient was diagnosed with an umbilical hernia, which was not present prior to the patient beginning pd for rrt.The pdrn reported the patient was experiencing frequent drain complications.On (b)(6) 2022, the patient successfully underwent an outpatient umbilical hernia repair, and was released from the hospital in stable condition later the same day.Per the pdrn, no fresenius product(s) and/or device(s) deficiency or malfunction occurred; however, the patient¿s umbilical hernia developed since he began pd therapy for rrt.As of (b)(6) 2022, the patient¿s alzheimer¿s had worsened, and he has become combative.The patient¿s spouse is elderly and cannot continue caring for her spouse.As such, the patient will be transitioned to hemodialysis (hd) in the next week, after receiving an hd dialysis catheter (not a fresenius product).The patient will then transition to an outpatient hd clinic for rrt.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed with no physical damage noted.An (as-received) simulated therapy was initiated and completed on the cycler without complication.The weighed fill volumes were found to be within tolerance and fill times were within specification.The cycler underwent system air leak and valve actuation testing and was found to meet product specifications.There were no visual discrepancies encountered during the internal inspection.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.

Manufacturer Narrative

Correction provided in g1.

Event Description

On 28/apr/2022, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) underwent hernia surgery (date not provided).Follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient was diagnosed with an umbilical hernia, which was not present prior to the patient beginning pd for rrt.The pdrn reported the patient was experiencing frequent drain complications.On (b)(6) 2022, the patient successfully underwent an outpatient umbilical hernia repair, and was released from the hospital in stable condition later the same day.Per the pdrn, no fresenius product(s) and/or device(s) deficiency or malfunction occurred; however, the patient¿s umbilical hernia developed since he began pd therapy for rrt.As of (b)(6) 2022, the patient¿s alzheimer¿s had worsened, and he has become combative.The patient¿s spouse is elderly and cannot continue caring for her spouse.As such, the patient will be transitioned to hemodialysis (hd) in the next week, after receiving an hd dialysis catheter (not a fresenius product).The patient will then transition to an outpatient hd clinic for rrt.

• 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: 14336415
• MDR Text Key: 291213532
• Report Number: 0002937457-2022-00751
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2021
• 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; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male