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

Catalog Number RTLR180111

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumonia (2011)

Event Date 08/16/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A peritoneal dialysis (pd) patient stated he was in the hospital and was having difficulty with his dialysis cycler.The patient sounded slightly incoherent.Follow-up was made with the pd patient's clinic registered nurse (rn), who stated the patient was in the hospital being treated for pneumonia.Per pdrn, the patient was a smoker, but had no history of copd/asthma or bronchitis.The pdrn reported the patient had hypertension, but was unable to provide a list of concomitant medications.The pdrn stated that she believed the was bacterial in nature, but was not too sure since as of (b)(6) 2017 the patient was still in the hospital.Pdrn was also unable to provide information regarding the possibility of recent fluid overload or hypervolemia.Medical records were requested.

Manufacturer Narrative

Conclusion: a review of the file information was conducted and revealed the patient had been hospitalized on (b)(6) 2017 for an unknown length of time for pneumonia.Pneumonia is a known risk factor in immunocompromised patients and is most often a community acquired infection.During the hospitalization the patient continued to perform continuous cyclical peritoneal dialysis (ccpd); although it is unknown if fresenius products were utilized.There is no documentation or indication to show a relationship between the patient's reported hospitalization for pneumonia and any fresenius products.There was no allegation against any fresenius products.If additional information becomes available, the need for a clinical investigation will be re-evaluated accordingly.The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformance during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.

Event Description

A peritoneal dialysis (pd) patient stated he was in the hospital and was having difficulty with his dialysis cycler.The patient sounded slightly incoherent.Follow-up was made with the pd patient's clinic registered nurse (rn), who stated the patient was in the hospital being treated for pneumonia.Per pdrn, the patient was a smoker, but had no history of copd/asthma or bronchitis.The pdrn reported the patient had hypertension, but was unable to provide a list of concomitant medications.The pdrn stated that she believed the was bacterial in nature, but was not too sure since as of (b)(6) 2017 the patient was still in the hospital.Pdrn was also unable to provide information regarding the possibility of recent fluid overload or hypervolemia.Medical records were requested.

• 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: 6808315
• MDR Text Key: 83177943
• Report Number: 2937457-2017-00755
• 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,health professional
• Reporter Occupation: Patient
• 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: 08/21/2017
• 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
• Date Manufacturer Received: 08/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2015
• 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: LIBERTY CYCLER CASSETTE; PD SOLUTION
• Patient Outcome(s): Hospitalization; Required Intervention