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

Catalog Number RTLR180111

Device Problems Overheating of Device (1437); Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

The cycler was returned for evaluation.Visual inspection of the returned cycler exterior showed no sign of physical damage.There are visual indications of dried fluid within the cassette compartment.No burrs or sharps in cassette area that may have punctured a cassette membrane.During the ¿set-up¿ phase of the simulated treatment an "motor pump a¿ alarm occurred three times and the treatment was canceled.Passed mushroom head check.When removing the heater tray a burnt odor was present.An internal inspection of the cycler found c76 (capacitor) on the i/o board was heat damaged.C76 is connect to output pin 3 of ic35 (voltage regulator) which provides +12 volts.A measurement of ic35 output pin 3 showed.09 volts.¿patient sensors 1 and 2¿ requires 12 volts to function.A review of ¿patient sensors 1 and 2¿ in ¿diagnostics mode¿ show sensor 1 displayed reading of (-314/-4.5) and sensor 2 (-308/-4.4).In addition, there was 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 could not be determined.The reported symptoms were confirmed.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device manufacturing review confirmed the labeling, material, and process controls were within specification.

Event Description

A peritoneal dialysis nurse reported the cycler had an alarm for "patient vacuum too high" during the patient's last drain.The nurse also reported a burning smell and visible smoke came from the back of the cycler.Treatment was discontinued and the cycler was replaced.During follow up the clinic confirmed there was no injury to the patient.

• Brand Name: LIBERTY 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: 6815723
• MDR Text Key: 83691437
• Report Number: 2937457-2017-00774
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2017
• 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