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 05/20/2017

Event Type  Injury  

Manufacturer Narrative

The plant investigation has not yet been completed.A follow up report will be filed upon completion of the investigation.Although a temporal relationship may exists between the fresenius products and patients¿ probable respiratory symptoms, and subsequent development of pneumonia requiring hospitalization, the likely causality of the pneumonia/hospitalization is the patient¿s significant medical history of lung cancer which may pre dispose the patient to the development of pneumonia.

Event Description

Peritoneal dialysis nurse reported that a peritoneal dialysis patient was hospitalized on an unknown date and treated for bacterial pneumonia and was treated with antibiotics.Patient reported difficulties with drain complications.At the time of the call with the peritoneal dialysis nurse, the patient was receiving dialysis treatments in the hospital.Additional information was solicited.

Manufacturer Narrative

Corrected date of event: (b)(6) 2017 although a temporal relationship may exists between the fresenius products and patients¿ probable respiratory symptoms, and subsequent development of pneumonia requiring hospitalization, the likely causality of the pneumonia/hospitalization is the patient¿s significant medical history of lung cancer which may pre dispose the patient to the development of pneumonia.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.A visual inspection of the returned cycler exterior showed no sign of physical damage.Simulated treatment was performed and completed without any unexpected alarms or problems occurring.The valve actuation test and system air leak test passed.An internal inspection of the cycler found the front support rubber grommet of the air supply assembly is missing and could not be located.No other discrepancies were encountered in the internal inspection of the cycler.The record review confirmed the labeling, material, and process controls were within specification.There were no reported device malfunctions that would have caused the reported event.

Event Description

Source documents and information in the complaint file were reviewed by a post market surveillance clinician.On (b)(6) 2017 it was reported by a peritoneal dialysis (pd) patient's clinic registered nurse (rn), this pd patient was admitted to the hospital on (b)(6) 2017 with a diagnosis of pneumonia.The patient had been having reported difficulties with drain complications and had not completed pd treatments with his cycler.The patient was receiving pd treatments while hospitalized, and as of (b)(6) 2017 the patient remained hospitalized.

• 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: 6645219
• MDR Text Key: 77707262
• Report Number: 2937457-2017-00475
• 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,Followup
• Report Date: 07/01/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 05/23/2017
• Initial Date FDA Received: 06/15/2017
• Supplement Dates Manufacturer Received: 06/28/2017
• Supplement Dates FDA Received: 07/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2008
• 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): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 78