MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA, CONCORD MANUFACTURING LIBERTY DIALYSIS CYCLER

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

Patient Problems Dyspnea (1816); Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Weakness (2145)

Event Date 04/20/2015

Event Type  Injury  

Event Description

A peritoneal dialysis nurse (pdrn) reported that a peritoneal dialysis pt was admitted to the er/hosp for acute dehydration.Upon receipt of med records, it was found that pt had shortness of breath and had hypotension.Pt is an (b)(6) male who presented at the emergency room on (b)(6) 2015 due to progressive weakness, fatigue, shortness of breath, and hypotension.The pt never rebounded after being discharged recently from the hosp for intractable diarrhea.In the emergency room the pt had blood pressure in the 70s.His appetite was poor.The pt was admitted to the hosp and placed on intravenous hydration and started on rocephin.His antihypertensives were held and he continued on ciprofloxacin.

Manufacturer Narrative

Based on the med records info, it appears that on (b)(6) 2015 this pt was admitted into the hosp due to failure to thrive at home, weakness, dizziness, and progressive shortness of breath.He had recently been hospitalized for diarrhea and sent home.However, the pt grew progressively worse at home.The pt was treated with intravenous fluids and antibiotics.Med records do not contain any culture results for review.The pt's discharge summary is not available for review.There is no documentation in the med record that shows a casual relationship between the pt's hospitalization for failure to thrive and his liberty cycler.The device was not returned to the mfr for physical eval and the failure mode cannot be confirmed.However, an investigation of the device mfg records was conducted by the mfr.There were no deviations or nonconformities during the mfg process.In addition, the dhr review confirmed the labeling, material, and process controls were within specification.

• Brand Name: LIBERTY DIALYSIS CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA, CONCORD MANUFACTURING; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA, CONCORD PLANT; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st; waltham, MA 02451-1457 ; 8006621237
• MDR Report Key: 4794505
• MDR Text Key: 5813616
• Report Number: 2937457-2015-00970
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: PRAVACHOL; LIBERTY CYCLER TUBING; EPOGEN; LUTEIN; IMBRUVICA; ELIQUIS; PD SOLUTIONS
• Patient Outcome(s): Hospitalization; Required Intervention