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

Catalog Number RTLR180343

Device Problem Device Issue (2379)

Patient Problem Hernia (2240)

Event Date 02/16/2018

Event Type  Injury  

Manufacturer Narrative

A possible association exists between the liberty select cycler and the reported adverse event(s) of iipv and inguinal hernia.Follow-up efforts revealed the patient¿s inguinal hernia was a known pre-existing condition prior to the initiation of pd therapy.Additionally, the reported drain volume 4,003 ml on (b)(6) 2018 after drain cycle #2 did not meet the criteria of >180% of the largest fill volume (fv) of 2,499 ml which would be 4,498 ml.Based on the information available, there is no documentation or indication that any fresenius device(s) caused or contributed to a serious adverse patient outcome.Additionally, there is no allegation of a machine malfunction or a machine failing to perform as expected.Increased intra-abdominal pressure associated with pd therapy is known to create or exacerbate pre-existing weaknesses in the supporting abdominal wall structures.Additionally, the placement of a pd catheter is a risk factors for increased likelihood of hernia formation or enlargement.Hernias are a known complication of pd therapy, therefore causality cannot be fully determined.A supplemental mdr will be submitted upon device evaluation.

Event Description

A peritoneal dialysis patient reported his cycler had alarmed for ¿supply bag lines are blocked¿ alarms and a reported overfill on (b)(6) 2018.Additionally the patient stated he was having hernia (specifics unknown) surgery on (b)(6) 2018.The cycler was replaced.With regard to the reported event of increased intraperitoneal volume (iipv), the patient noted a drain volume 4,003 ml after drain cycle #2 had been completed.The drain volume was assessed for malfunction overfill and did not meet the criteria of >180% of the largest fill volume (fv) of 2,499 ml which would be 4,498 ml.During a follow-up call on (b)(6) 2018 the peritoneal dialysis registered nurse (pdrn) confirmed the patient underwent inguinal hernia repair on (b)(6) 2018.Reportedly the inguinal hernia repair was performed outpatient, and the patient was transitioned to hemodialysis (hd) for approximately 4 weeks while recovering.The pdrn reported the inguinal hernia was a known condition prior to beginning pd therapy.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed with no physical damage noted.A simulated therapy was initiated and completed on the cycler without complication.The weighed fill volumes were found to be within tolerance.The cycler underwent system air leak and valve actuation testing and was found to meet product specifications.Load cell verification testing was performed with no issues noted.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: LIBERTY SELECT CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7340260
• MDR Text Key: 102433079
• Report Number: 2937457-2018-00776
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Device Age: MO
• Date Manufacturer Received: 03/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX DIALYSIS SOLUTION; LIBERTY CYCLER SET
• Patient Outcome(s): Other; Required Intervention