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 Dehydration (1807); High Blood Pressure/ Hypertension (1908)

Event Date 04/08/2023

Event Type  Injury  

Event Description

During a follow-up call to the patient for an balloon valve leak occurring on (b)(6) 2023, the patient reported not completing pd therapy on that date and being hospitalized for dehydration.The date of the hospital admission was not confirmed.The patient stated during the hospitalization they were dialyzed and then discharged on (b)(6) 2023.The patient reported they are currently completing in-center hd.The reason for completing hd was not provided.Attempts to obtain additional information were unsuccessful.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.Additionally, there is no allegation that the liberty select cycler or other fresenius product(s) was the cause of the patient¿s dehydration and hospitalization.

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

During a follow-up call to the patient for an balloon valve leak occurring on (b)(6) 2023, the patient reported not completing pd therapy on that date and being hospitalized for dehydration.The date of the hospital admission was not confirmed.The patient stated during the hospitalization they were dialyzed and then discharged on (b)(6) 2023.The patient reported they are currently completing in-center hd.The reason for completing hd was not provided.Attempts to obtain additional information were unsuccessful.

Manufacturer Narrative

Additional information provided in a2, a3, a4, b5, b6, g2, h6, and h10.Clinical review: dehydration and a loss of water in the body often leads to an imbalance of electrolytes.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.Additionally, there is no allegation that the liberty select cycler or other fresenius product(s) was the cause of the patient¿s dehydration with hypertension and hospitalization.

Event Description

Additional information was provided in response by the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was in treatment on (b)(6) 2023 when he was not feeling well.The patient cancelled the treatment and went to the hospital.The patient was admitted to the hospital with a diagnosis of dehydration and hypertension.The pdrn did not confirm the patient¿s date of discharge.The pdrn stated the hospitalization was unrelated to any fresenius device(s) or product(s) and/or their dialysis therapy.A cause of the dehydration and hypertension was not provided.The patient completed hemodialysis during the hospitalization.The patient continued hd with in-center dialysis to correct electrolyte imbalances (unspecified).The patient plans to return to pd therapy.Dehydration and a loss of water in the body often leads to an imbalance of electrolytes.

Event Description

Additional information was provided in response by the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was in treatment on (b)(6) 2023 when he was not feeling well.The patient cancelled the treatment and went to the hospital.The patient was admitted to the hospital with a diagnosis of dehydration and hypertension.The pdrn did not confirm the patient¿s date of discharge.The pdrn stated the hospitalization was unrelated to any fresenius device(s) or product(s) and/or their dialysis therapy.A cause of the dehydration and hypertension was not provided.The patient completed hemodialysis during the hospitalization.The patient continued hd with in-center dialysis to correct electrolyte imbalances (unspecified).The patient plans to return to pd therapy.Dehydration and a loss of water in the body often leads to an imbalance of electrolytes.

Manufacturer Narrative

Correction: g3 - the date received was incorrectly reported on the initial submission of this mdr as 04/08/2023.The correct date is 04/11/2023.

Manufacturer Narrative

Additional information provided in d9 and h3.An exterior visual inspection of the returned cycler showed no sign of physical damage.An (as-received) simulated treatment was performed and completed.The cycler weighed fill volume values were within tolerance for a liberty cycler.The cycler underwent and passed a system air leak test and valve actuation test.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.

Event Description

Additional information was provided in response by the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was in treatment on (b)(6) 2023 when he was not feeling well.The patient cancelled the treatment and went to the hospital.The patient was admitted to the hospital with a diagnosis of dehydration and hypertension.The pdrn did not confirm the patient¿s date of discharge.The pdrn stated the hospitalization was unrelated to any fresenius device(s) or product(s) and/or their dialysis therapy.A cause of the dehydration and hypertension was not provided.The patient completed hemodialysis during the hospitalization.The patient continued hd with in-center dialysis to correct electrolyte imbalances (unspecified).The patient plans to return to pd therapy.Dehydration and a loss of water in the body often leads to an imbalance of electrolytes.

• 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: 16795458
• MDR Text Key: 313824019
• Report Number: 0002937457-2023-00602
• 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,Followup,Followup,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Device Age: MO
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2010
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 64 KG