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 Abdominal Pain (1685); Diarrhea (1811); Malaise (2359)

Event Date 11/25/2019

Event Type  Injury  

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.Clinical investigation: a temporal relationship exists between continuous cycling peritoneal dialysis (ccpd) therapy utilizing the liberty select cycler and the adverse events of malaise, abdominal pain and diarrhea, which warranted hospitalization and unspecified medical intervention.Although the etiology of the events is unknown, the patient has been experiencing on-going gi complications and is scheduled for further gi evaluation with the gastroenterologist.Per the pdrn, the events were unrelated to the utilization of the liberty select cycler or any fresenius device(s) or product(s).Gi complications are known to commonly occur in patients with kidney failure.The most common complications are nausea, vomiting, abdominal pain, constipation and diarrhea.Based on the information available, the liberty select cycler set can be disassociated, as there is no allegation or objective evidence indicating a fresenius product or device deficiency or malfunction caused or contributed to the serious adverse events experienced by the patient.

Event Description

A peritoneal dialysis (pd) patient contacted fresenius technical support and they are receiving unspecified drain alarms.The patient was no longer in treatment at the time of the call.Upon follow-up, the patient contact stated that the patient did not complete treatment on the cycler and went to the hospital the same night because they "did not feel right".Additional information was received from the patient's peritoneal dialysis registered nurse (pdrn) and confirmed the patient was hospitalized on (b)(6) 2019 for abdominal pain and diarrhea.The patient was treated (specifics not provided), and the patient was transferred to a rehabilitation hospital on (b)(6) 2019 for deconditioning.The patient remains at the rehabilitation hospital and is recovering from the events.The cause of the events is still being evaluated.The patient has been experiencing on-going gastrointestinal (gi) complications and has multiple gi consults scheduled in the next couple weeks.The pdrn stated the events were unrelated to the utilization of the liberty select cycler or any fresenius device(s) or product(s).The pdrn stated the acute hospital discharge summary was requested, however it was unavailable at the time.

• 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: 9468514
• MDR Text Key: 170870368
• Report Number: 2937457-2019-03584
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• 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
• Device Age: MO
• Date Manufacturer Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2019
• 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: 80 YR
• Patient Weight: 98