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

Catalog Number RTLR180111

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Issue (2379); Device Operates Differently Than Expected (2913)

Patient Problems Pleural Effusion (2010); Hypervolemia (2664)

Event Date 10/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The medical records did not reveal any allegation against fresenius products.The patient¿s nurse reported the pleural effusion was due to pd treatment.The pleural effusion was probably related to peritoneal dialysis using fresenius products.The pleural fluid glucose result suggests there was peritoneal dialysis fluid in the pleural space.A follow up will be submitted following plant evaluation.

Event Description

A peritoneal dialysis (pd) patient called technical services stating the cycler was not draining him completely.He stated that when he spoke with his nurse they thought he was absorbing the fluid and that is why his legs were swollen.His treatment record for (b)(6) 2016 did not show any overfills.During follow up with the patient¿s nurse she reported the patient had experienced a pleural effusion due to a diaphragm leak along with fluid overload.She reported the pleural effusion was due to pd therapy.The patient was not hospitalized for the event.The following is from medical records provided by the patient¿s treatment facility.The patient presented to clinic complaining of a right side, lower chest upper abdomen atypical pain.He was also complaining of low grade fever with t max of 99f.

Manufacturer Narrative

The actual device was not returned to the manufacturer for physical evaluation.However, 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.

• 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: 6138846
• MDR Text Key: 61240215
• Report Number: 2937457-2016-01196
• Device Sequence Number: 1
• Product Code: FKX
• 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,health professional
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2009
• 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
• Treatment: DELFLEX PD SOLUTION; LIBERTY TUBING
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 59