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 Chest Pain (1776); Dyspnea (1816); High Blood Pressure/ Hypertension (1908)

Event Date 09/20/2022

Event Type  Injury  

Event Description

On 28/sep/2022, fresenius became aware this 41-year-old male patient on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was reportedly hospitalized due to uremia and fluid overload.A review of the discharge summary revealed the patient was hospitalized on (b)(6) 2022 due to shortness of breath (dyspnea), hypertension and chest pain.While admitted, the patient was successfully treated with ccpd therapy, and the addition of a new antihypertensive medication (clonidine added).On (b)(6) 2022, the patient had recovered from the serious adverse events was discharged home in stable condition.Per the discharge diagnoses, the patient was treated for malignant hypertension and non-compliance with peritoneal dialysis (no mention of fluid overload or uremia).Per the pdrn, the patient underwent ccpd therapy while hospitalized without issue, and encountered further drain complications following discharge.Therefore, the pdrn stated given these details, causality could not be firmly established.

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 events of dyspnea, hypertension, and chest pain which required hospitalization, medication adjustment, and additional ccpd therapy.Despite the patient¿s reported non-compliance, there is insufficient data to state the liberty select cycler did not cause/contribute to the serious adverse events.Hypertension is a common finding in the esrd community and is often ineffectively controlled.Furthermore, patient related factors, such as non-compliance, can be significant contributing factors.Based on the totality of the information available, the liberty select cycler cannot be excluded from having a possible causal/contributory role in the patient¿s serious adverse.There is no objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction caused/contributed to the events.If the cycler is returned, a manufacturer evaluation may dissociate the liberty select cycler from having caused/contributed to the serious adverse events.However, given the pdrn and patient¿s statement/allegations regarding the liberty select cycler, and no treatment records to review, this clinical investigation cannot disassociate the device from the serious adverse events.

Event Description

On 28/sep/2022, fresenius became aware this 41-year-old male patient on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was reportedly hospitalized due to uremia and fluid overload.A review of the discharge summary revealed the patient was hospitalized on 20/sep/2022 due to shortness of breath (dyspnea), hypertension and chest pain.While admitted, the patient was successfully treated with ccpd therapy, and the addition of a new antihypertensive medication (clonidine added).On 23/sep/2022, the patient had recovered from the serious adverse events was discharged home in stable condition.Per the discharge diagnoses, the patient was treated for malignant hypertension and non-compliance with peritoneal dialysis (no mention of fluid overload or uremia).Per the pdrn, the patient underwent ccpd therapy while hospitalized without issue, and encountered further drain complications following discharge.Therefore, the pdrn stated given these details, causality could not be firmly established.

Manufacturer Narrative

Correction:h1 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.

• 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: 15626052
• MDR Text Key: 307092070
• Report Number: 0002937457-2022-01738
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• 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: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2020
• 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: LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 97 KG