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); Vomiting (2144)

Event Date 11/22/2021

Event Type  Injury  

Manufacturer Narrative

Clinical statement: 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.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported that a patient was dehydrated to the point of throwing up and was admitted to the hospital for a week.Upon follow up, the patient¿s peritoneal dialysis registered nurse (pdrn) reported the patient¿s hospitalization was unrelated to any fresenius products, or the liberty select cycler.According to the pdrn, the patient had recently started pd therapy and was having a tough time adjusting.No further information was provided related to the cause of the patient¿s hospitalization.The pdrn stated the patient is fine now and doing well.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.

Event Description

It was reported that a patient was dehydrated to the point of throwing up and was admitted to the hospital for a week.Upon follow up, the patient¿s peritoneal dialysis registered nurse (pdrn) reported the patient¿s hospitalization was unrelated to any fresenius products, or the liberty select cycler.According to the pdrn, the patient had recently started pd therapy and was having a tough time adjusting.No further information was provided related to the cause of the patient¿s hospitalization.The pdrn stated the patient is fine now and doing well.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.

Manufacturer Narrative

Correction: h4 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13018227
• MDR Text Key: 282335080
• Report Number: 2937457-2021-02452
• 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: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• 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
• Device Age: MO
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2015
• 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): Hospitalization
• Patient Sex: Female