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

Model Number LIBERTY SELECT CYCLER

Device Problem Fluid/Blood Leak (1250)

Patient Problem Inflammation (1932)

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

The alleged event is not confirmed.The reported symptom (fluid leaking) was not confirmed.The complaint symptom alarm (unknown)¿ in the as-received alarm history refers to as (hb make sure hb is on ht tray) was not confirmed.The reported symptom code (m65 scale reading error warning) was not confirmed.A visual inspection of the returned cycler exterior showed no sign of physical damage.There are visual indications of dried fluid within the cassette compartment.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.The load cell verification passed.Accelerated stress test was perform and passed.No fluid leaks in the test cassette during the accelerated stress test.Mushroom head check passed.Positive for glucose.An internal visual inspection of the cycler found visual evidence of dried fluid under pump ¿a¿ and ¿b¿ mushroom head and within the recess of the bottom cover adjacent to the pump.The cause of the observed dried fluid and fluid could not be determined.A dhr review found mushroom head check: (b)(6) 2017, (b)(6) 2017.

Event Description

Peritoneal dialysis patient reported observing a fluid leak on the floor and in the liberty select cassette compartment.The cycler did alarm but the patient could not confirm the type of alarm that was encountered.Follow up with the patients peritoneal dialysis nurse indicates that the patient did have abdominal inflammation but was not diagnosed with any infection.The patient was prescribed prophylactic antibiotics, ip vancomycin 3 times a week and oral keflex.The liberty select cycler was replaced.

Manufacturer Narrative

Correction: weight.

Event Description

".".

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7333764
• MDR Text Key: 102210020
• Report Number: 2937457-2018-00752
• 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: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY SELECT CYCLER
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Device Age: MO
• Date Manufacturer Received: 04/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER SET; PD SOLUTION; LIBERTY CYCLER SET; PD SOLUTION
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 107