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

Model Number LIBERTY

Device Problems Air Leak (1008); Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2017

Event Type  malfunction  

Manufacturer Narrative

The device had not been returned to the manufacturer.A supplemental report shall be filed if the device is received.

Event Description

The patient contact reported that during the patient's previous night's treatment the cycler displayed m31 air detected in cassette.The patient was on a drain.The contact stated they ended the treatment.When the cycler door was opened to remove the cassette, it was noted that fluid was leaking.The cycler will be replaced.Tech support advised discontinuing use of the cycler.The has manual supplies and will confer with clinic regarding the next night's treatment.

Manufacturer Narrative

For 2937457-2017-00624 as follows: date of report: 09/06/2017.Date received by manufacturer: 08/10/2017.

Event Description

The patient contact reported that during the patient's previous night's treatment the cycler displayed m31 air detected in cassette.The patient was on a drain.The contact stated they ended the treatment.When the cycler door was opened to remove the cassette, it was noted that fluid was leaking.The cycler will be replaced.Tech support advised discontinuing use of the cycler.The has manual supplies and will confer with clinic regarding the next night's treatment.

Manufacturer Narrative

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.No burrs or sharps in cassette area that may have punctured a cassette membrane.A simulated treatment was performed and completed.No fluid leaks in the test cassette during the test treatment.An internal visual inspection of the cycler found evidence of dried fluid under pump ¿a¿ and ¿b¿ mushroom head and within the recess of the bottom cover adjacent to the pump.A device history record search found no related items.

Event Description

The patient contact reported that during the patient's previous night's treatment the cycler displayed m31 air detected in cassette.The patient was on a drain.The contact stated they ended the treatment.When the cycler door was opened to remove the cassette, it was noted that fluid was leaking.The cycler will be replaced.Tech support advised discontinuing use of the cycler.The has manual supplies and will confer with clinic regarding the next night's treatment.

• 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: 6744213
• MDR Text Key: 81143519
• Report Number: 2937457-2017-00624
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: LIBERTY
• Device Catalogue Number: RTLR180111
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2017
• 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
• Patient Age: 12 YR
• Patient Weight: 29