MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY CYCLER ASSEMBLY (NEW); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180111

Device Problem Infusion or Flow Problem (2964)

Patient Problem Pain (1994)

Event Date 07/21/2017

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

The peritoneal dialysis (pd) nurse for the patient reported that the patient was having back/shoulder pain due to air being introduced by the cycler.The patient does not have a history of back pain.The pd rn confirmed that the cycler was replaced to resolve the issue of air being introduced.No medical intervention was required as a result of this event.The patient was not hospitalized and no medications were prescribed for the pain.The patient has been on pd therapy for a little over a year.

Manufacturer Narrative

The event reported against the liberty cycler machine in mdr was submitted in error.The reported event of the patient having back/shoulder pain due to air being introduced by the cycler is not considered a mdr reportable event.There is no reported serious injury that had occurred in response to this event.

Event Description

Upon further review, this event is not a reportable event for which our marketed device may have caused or contributed to a death or serious injury, or has malfunctioned and the malfunction of the device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

• Brand Name: LIBERTY CYCLER ASSEMBLY (NEW)
• 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: 6801809
• MDR Text Key: 82978092
• Report Number: 2937457-2017-00744
• 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: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2011
• 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): Other