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 Abdominal Pain (1685); Chest Pain (1776); Peritonitis (2252)

Event Date 06/09/2022

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation:there is a temporal relationship between peritoneal dialysis utilizing the liberty select cycler with liberty cycler set and the patient event of peritonitis with hospitalization and subsequent transition to in-center hemodialysis.However, there is no documentation in the complaint file to show a causal relationship between the peritonitis event and use of the liberty select cycler or cycler set.Additionally, there is no allegation of a device malfunction or deficiency, or cycler set defect reported for this event.The patient¿s culture results, and the cause of the peritonitis were not available, but the patient contact reported a fungal infection, and the patient had the pd catheter removed which is indicative of a fungal organism.Per international society of peritoneal dialysis (ispd) guidelines for peritonitis, it is recommended that immediate catheter removal is appropriate when fungi are identified in pd effluent.All pd patients are at risk for infection due to a compromised immune system and dialysis techniques increase the potential of microbial contamination.Based on the limited information and no allegation or evidence of a defect, deficiency, or malfunction, the liberty select cycler and liberty cycler set can be excluded as the cause of the patient¿s peritonitis.The patient¿s chest pain was related to an unspecified cardiac event.There is no documentation or evidence to suggest the pain began during pd treatment.The pdrn stated the patient first reported the pain while in the clinic on (b)(6) 2022.There is no indication of a serious injury or other adverse event related to a fresenius device, product, or drug related to the cardiac event.Therefore, the liberty select cycler can be excluded as the cause of the chest pain and eventual cardiac event.

Event Description

A peritoneal dialysis (pd) patient contact called fresenius customer service to report the patient was hospitalized due to a heart issue and a fungal infection was found on their port.It was reported while hospitalized the nurse requested the patient transition to in center therapy.Upon follow up, the pdrn stated the patient initially contacted the clinic (b)(6) 2022 with complaints of abdominal pain.The patient was instructed to take 2g intraperitoneal (ip) vancomycin.On (b)(6) 2022 the patient was seen in the clinic for a vancomycin trough draw.The pd effluent was clear.At that time the patient reported continued abdominal pain and additionally reported chest pain.The patient was referred to the emergency room from the clinic.The patient was found to have had an unspecified cardiac event and was admitted to the hospital on (b)(6) 2022.A pd effluent culture was also obtained, and the patient was diagnosed with peritonitis.The pdrn could not find any culture results or antibiotic therapy listed for the hospitalization.The patient¿s pd catheter was removed during their hospitalization.The patient was transitioned to in-center hemodialysis (hd).The patient was discharged from the hospital on an unknown date.It is unknown whether the patient can return to pd therapy.Additional details surrounding the patient¿s hospital course and condition were requested, however, not provided due to the patient being discharged from the clinic.

Event Description

A peritoneal dialysis (pd) patient contact called fresenius customer service to report the patient was hospitalized due to a heart issue and a fungal infection was found on their port.It was reported while hospitalized the nurse requested the patient transition to in center therapy.Upon follow up, the pdrn stated the patient initially contacted the clinic (b)(6) 2022 with complaints of abdominal pain.The patient was instructed to take 2g intraperitoneal (ip) vancomycin.On (b)(6) 2022 the patient was seen in the clinic for a vancomycin trough draw.The pd effluent was clear.At that time the patient reported continued abdominal pain and additionally reported chest pain.The patient was referred to the emergency room from the clinic.The patient was found to have had an unspecified cardiac event and was admitted to the hospital on (b)(6) 2022.A pd effluent culture was also obtained, and the patient was diagnosed with peritonitis.The pdrn could not find any culture results or antibiotic therapy listed for the hospitalization.The patient¿s pd catheter was removed during their hospitalization.The patient was transitioned to in-center hemodialysis (hd).The patient was discharged from the hospital on an unknown date.It is unknown whether the patient can return to pd therapy.Additional details surrounding the patient¿s hospital course and condition were requested, however, not provided due to the patient being discharged from the clinic.

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.

• 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: 15103646
• MDR Text Key: 296585336
• Report Number: 0002937457-2022-01232
• 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: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 07/27/2022
• Supplement Dates FDA Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2017
• 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; LIBERTY CYCLER SET ; LIBERTY CYCLER SET
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male