MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER

Model Number LIB

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

Patient Problem Peritonitis (2252)

Event Date 12/20/2015

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plants investigation and a review of medical records, if received.

Event Description

During a call to technical support, the patient reported drain complications.A follow up call placed to the patient's pdrn and it was reported the patient was hospitalized for peritonitis on (b)(6) 2015.She was unaware of the potential cause of the infection and reported the patient is usually compliant with aseptic technique.She stated antibiotics were started, but is not aware of the typo or if cultures were drawn.No other information or medical records were available at this time.

Manufacturer Narrative

A visual inspection was performed on the returned device and there were no signs of any physical damage with the received cycler.An internal inspection was performed and there were no discrepancies encountered in the internal inspection of the cycler.Simulated testing was performed and the device performed without failures.Device history review was performed and found no non-conformance reports or other abnormalities during the manufacturing process.The product involved met current specifications.In addition, the device record review confirmed the labeling, material, and process controls were within specification.The system level review of cycler and concomitant products found no indication that the products caused or contributed in any way to the clinical event.

Manufacturer Narrative

(b)(4).The device code was updated to reflect corrected data for this reported event.

Event Description

Additional information received from the patient's peritoneal dialysis registered nurse reported the patient was initially hospitalized on (b)(6) 2015 and diagnosed with peritonitis.The patient was treated with vancomycin and ceftazidime and discharged on (b)(6) 2015.After discharge the patient's pd catheter became clogged and the patient was not able to drain during dialysis until (b)(6) 2015.The patient had no heparin or manual supplies at home at that time.The patient was subsequently readmitted to the hospital on (b)(6) 2015 for the unresolved peritonitis.During this hospital stay the patient had a hemodialysis catheter placed and the pd catheter was removed.The patient was discharged from the hospital on (b)(6) 2016 to in-center hemodialysis beginning on (b)(6) 2016.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter street; waltham , MA 02451-1457 ; 7816999000
• MDR Report Key: 5346689
• MDR Text Key: 35284306
• Report Number: 2937457-2015-01763
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIB
• Device Catalogue Number: (RTLR) 180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Date Manufacturer Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention