MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180343

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

Patient Problems Death (1802); Obstruction/Occlusion (2422)

Event Date 01/16/2018

Event Type  Death  

Manufacturer Narrative

Device evaluation: the actual product was not returned for investigation, therefore, it was not possible to confirm failure mode.A serial number review could not be performed as no serial number was available.

Event Description

Information was received that a peritoneal dialysis patient had expired.Upon further follow up with the patient's nurse, it was confirmed that stated that the patient was hospitalized on (b)(6) 2018 for bowel obstruction.The treatment rendered at the hospital was unknown, however, the patient was transitioned to hemodialysis and passed away few days later on (b)(6) 2018.The patient was not dialyzing nor was connected to the cycler at the time of death.The cause of death was stated to be small bowel obstruction.

Manufacturer Narrative

Clinical evaluation: a temporal association exists between ccpd therapy with the liberty select cycler and the patient¿s adverse event(s) of abdominal pain which required hospitalization related to small bowel obstruction and gastrointestinal hemorrhage.During hospitalization, the patient was transitioned to hd therapy (unknown products and treatment details).Subsequently the patient¿s health status continued to decline with significant hypotension and cardiac arrhythmias, and on (b)(6) 2018 the patient expired.Based on the available information, the etiology for the patient¿s sbo and gastrointestinal hemorrhage is unknown.It is known that patients with esrd on pd therapy may develop gastrointestinal complications such as small bowel obstruction and gastrointestinal hemorrhage.Therefore, it is possible ccpd therapy with the liberty select cycler may have been a potential factor in the patient¿s sbo and gastrointestinal hemorrhage event.However, at the time of this clinical investigation, there have been no reported allegations against or documentation that indicates the liberty select cycler malfunctioned in any way to cause or contribute to the event.Furthermore, the hospital discharge summary states the preliminary cause of death as sbo, with secondary cause listed as esrd.However, the patient¿s esrd death notification or death certificate is not available at this time and therefore actual cause of death cannot be determined.Should additional information become available, this clinical investigation will be re-evaluated accordingly.

Event Description

Information was received that a peritoneal dialysis patient had expired.Upon further follow up with the patient's nurse, it was confirmed that stated that the patient was hospitalized on (b)(6) 2018 for bowel obstruction.The treatment rendered at the hospital was unknown, however, the patient was transitioned to hemodialysis and passed away few days later on (b)(6) 2018.The patient was not dialyzing nor was connected to the cycler at the time of death.The cause of death was stated to be small bowel obstruction.

• Brand Name: LIBERTY SELECT CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7327123
• MDR Text Key: 101988919
• Report Number: 2937457-2018-00735
• 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: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Event Location: Hospital
• Date Manufacturer Received: 03/13/2018
• 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): Death
• Patient Age: 64 YR