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 Hypervolemia (2664)

Event Date 02/16/2022

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: a temporal relationship exists between continuous cyclic peritoneal dialysis (ccpd) therapy utilizing the liberty select cycler, and the patient¿s serious adverse event of hypervolemia which warranted hospitalization.The etiology of the event is unknown; therefore, causality cannot firmly be established.However, the patient resumed utilizing the same liberty select cycler without any reported issues.Hypervolemia is a well-known potential complication of the end stage renal dialysis (esrd) process.Causality can often be attributed to several different internal and external factors such as, physiological changes, mechanical issues, membrane/transport failure.Based on the available information, the patient¿s liberty select cycler is disassociated from the events.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction occurred.

Event Description

On 19/feb/2022, during follow-up for file (b)(4), fresenius became aware this male patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized due to a buildup of fluid in the lungs (hypervolemia).No additional information provided during intake.During follow-up, the patient¿s pd registered nurse (pdrn) confirmed the patient was hospitalized (date not provided) due to hypervolemia.The pdrn was unable to confirm what caused the accumulation of pulmonary fluid, however the symptoms did not develop while the patient was undergoing pd therapy.The patient was reportedly discharged on (b)(6) 2022 and has recovered from the events.Following discharge, the patient continued to perform ccpd therapy utilizing the same liberty select cycler without issue.

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, during follow-up for file (b)(4) fresenius became aware this male patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized due to a buildup of fluid in the lungs (hypervolemia).No additional information provided during intake.During follow-up, the patient¿s pd registered nurse (pdrn) confirmed the patient was hospitalized (date not provided) due to hypervolemia.The pdrn was unable to confirm what caused the accumulation of pulmonary fluid, however the symptoms did not develop while the patient was undergoing pd therapy.The patient was reportedly discharged on (b)(6) 2022 and has recovered from the events.Following discharge, the patient continued to perform ccpd therapy utilizing the same liberty select cycler without issue.

Manufacturer Narrative

Correction b3, g3 was incorrect on the initial mdr, the correct date is (b)(6) 2022.

Event Description

On (b)(6) 2022, during follow-up for file c-907872, fresenius became aware this male patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized due to a buildup of fluid in the lungs (hypervolemia).No additional information provided during intake.During follow-up, the patient¿s pd registered nurse (pdrn) confirmed the patient was hospitalized (date not provided) due to hypervolemia.The pdrn was unable to confirm what caused the accumulation of pulmonary fluid, however the symptoms did not develop while the patient was undergoing pd therapy.The patient was reportedly discharged on (b)(6) 2022 and has recovered from the events.Following discharge, the patient continued to perform ccpd therapy utilizing the same liberty select cycler without issue.

• 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: 13733185
• MDR Text Key: 287014175
• Report Number: 2937457-2022-00374
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2017
• 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): Hospitalization; Required Intervention
• Patient Sex: Male