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); Fatigue (1849); Peritonitis (2252); Confusion/ Disorientation (2553)

Event Date 06/28/2021

Event Type  Injury  

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.As a serial number could not be determined, device history and manufacturing records could not be reviewed.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Clinical investigation: a temporal relationship exists between the pd therapy with the liberty select cycler/liberty cycler set and the patient¿s peritonitis event.However, there is no allegation nor any objective evidence that a liberty select cycler/ liberty cycler set malfunction or product deficiency was associated with this event.Based on the reported information, the cause of the patient¿s peritonitis cannot be determined.Peritonitis is a well-documented complication in patients undergoing pd therapy.The patient¿s pd culture yielded growth of pseudomonas which is an organism that is widely found in the environment and therefore may have been related to a breach in aseptic technique as initially reported by the pd nurse.Furthermore, the patient was elderly with a past medical history of dementia, failure to thrive with poor appetite and being considered for hospice prior to this event.During the hospitalization, the patient was transitioned to hospice care, discontinued dialysis and subsequently expired.Based on the reported information, the death was not related to fresenius products.

Event Description

It was reported a peritoneal dialysis (pd) patient was having symptoms of confusion and was hospitalized with peritonitis.There were no reported issues with any fresenius products in relation to the event.It was stated by a pd registered nurse (pdrn) that the fresenius cycler was working well and that the event may have been related to touch contamination.In additional follow-up, the patient¿s pdrn reported this (b)(6) patient has a past medical history of dementia when reporting the symptom of confusion.The nurse stated patient¿s overall health in the setting of dementia and failure to thrive (with poor appetite) had prompted the discussion of hospice prior to being hospitalized.Subsequently, the patient developed symptoms of fatigue and abdominal pain.As a result, on (b)(6) 2021, the patient was hospitalized and diagnosed with peritonitis.Reportedly, while hospitalized the patient had a pd culture obtained (date unknown) which yielded growth of the organism pseudomonas.The patient was treated with antibiotics (unknown medication) via intra-peritoneal administration.The nurse states the patient¿s wife had been performing pd treatments for the patient prior to hospitalization.The nurse was not able to identify the exact cause of the peritonitis event.However, the nurse confirmed the patient did not have any fluid leaks or any issues with fresenius device or product in relation to the peritonitis event.According to the nurse, during this hospitalization the patient¿s family subsequently decided to place the patient on hospice and the patient stopped all dialysis in the hospital.Subsequently, on (b)(6) 2021, the patient expired from natural causes.

• 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 12250773
• MDR Text Key: 264792435
• Report Number: 2937457-2021-01580
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/30/2021

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: 07/12/2021
• Initial Date FDA Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR