MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180343

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Peritonitis (2252)

Event Date 01/05/2024

Event Type  Injury  

Manufacturer Narrative

Plant investigation: 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 pd therapy utilizing the liberty select cycler with liberty cycler set and the patient event of peritonitis with hospitalization.However, there is no documentation in the complaint record to show a causal relationship between the use of the liberty select cycler and cycler set and the peritonitis event.Regardless of any allegation of a device malfunction or deficiency, or cycler set defect reported for this peritonitis event, there was a report of a solution bag leak (not a medical device) during set-up of the patient¿s pd treatment.The spouse re-set up the treatment with a new solution bag and connector but did not replace the cassette which could have come into contact with the leaking solution resulting in the patient¿s peritonitis.This cannot be confirmed as the culture resulted in negative growth, which sometimes occurs in patients with clinical findings of peritonitis.The most common cause of culture-negative cases is initiation of antibiotics before cultures are obtained.Although the cause of the peritonitis was not identified, most cases of pd peritonitis result from touch contamination of the catheter or the connections, which could have occurred during set-up of the patient¿s treatment.Based on the available information and no allegation of a malfunction, deficiency, or defect, the liberty select cycler and cycler set can be excluded as the cause of the patient¿s peritonitis event.

Event Description

A peritoneal dialysis registered nurse (pdrn) contacted fresenius customer service on (b)(6) 2024 to report this peritoneal dialysis (pd) patient was hospitalized with a diagnosis of peritonitis.Additional information was obtained through follow-up with the peritoneal dialysis registered nurse (pdrn) on (b)(6) 2024.The patient called the pd clinic on (b)(6) 2024 with complaints of weakness and low blood pressure.Additionally, the patient was below dry weight (weight not provided).The patient did not report any abdominal pain.The pdrn stated the patient has a history of pulling off too much fluid during treatments and the clinic thought he may be dehydrated.The patient was instructed to go to the emergency room (er) for evaluation.Bloodwork was obtained.The patient¿s white blood cell count was 329 with 49% polymorphonuclear cells.The patient had urine and blood cultures taken.The patient was admitted to the hospital and diagnosed with peritonitis based on the lab values.The patient was initiated on antibiotic therapy with vancomycin (route, dose, and frequency unknown).The cultures were both negative for growth.The patient was discharged from the hospital on (b)(6) 2024.The patient continued the vancomycin with the last dose on (b)(6) 2024.The pdrn stated that during the patient¿s pd treatment on (b)(6) 2024, the initial bag of solution was leaking.The patient¿s spouse changed out the solution and connectors; however, the cassette was not changed.The pdrn stated that this could have been the cause of the patient¿s peritonitis event, but no cause had been confirmed.No further information was provided.

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

A peritoneal dialysis registered nurse (pdrn) contacted fresenius customer service on (b)(6) 2024 to report this peritoneal dialysis (pd) patient was hospitalized with a diagnosis of peritonitis.Additional information was obtained through follow-up with the peritoneal dialysis registered nurse (pdrn) on (b)(6) 2024.The patient called the pd clinic on (b)(6) 2024 with complaints of weakness and low blood pressure.Additionally, the patient was below dry weight (weight not provided).The patient did not report any abdominal pain.The pdrn stated the patient has a history of pulling off too much fluid during treatments and the clinic thought he may be dehydrated.The patient was instructed to go to the emergency room (er) for evaluation.Bloodwork was obtained.The patient¿s white blood cell count was 329 with 49% polymorphonuclear cells.The patient had urine and blood cultures taken.The patient was admitted to the hospital and diagnosed with peritonitis based on the lab values.The patient was initiated on antibiotic therapy with vancomycin (route, dose, and frequency unknown).The cultures were both negative for growth.The patient was discharged from the hospital on (b)(6) 2024.The patient continued the vancomycin with the last dose on (b)(6) 2024.The pdrn stated that during the patient¿s pd treatment on (b)(6) 2024, the initial bag of solution was leaking.The patient¿s spouse changed out the solution and connectors; however, the cassette was not changed.The pdrn stated that this could have been the cause of the patient¿s peritonitis event, but no cause had been confirmed.No further information was provided.

• 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: 18560888
• MDR Text Key: 333435375
• Report Number: 0002937457-2024-00124
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2016
• 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; PD SOLUTION; PD SOLUTION
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male