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

Catalog Number RTLR180111

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

Patient Problems Fatigue (1849); Weakness (2145)

Event Date 03/01/2015

Event Type  Injury  

Event Description

During a follow up call, the peritoneal dialysis (pd) nurse reported the pd pt was in the hosp due to weakness.The pdrn did not know the exact date the pt was admitted or what caused his hospitalization.The pdrn stated the pt was transferred to hemodialysis during his hospital admission.

Manufacturer Narrative

The device was not returned to the mfr for physical eval.However, an investigation of the device mfg records was conducted by the mfr.There were no deviations or nonconformances during the mfg process.In addition, the batch record review confirmed the labeling, material, and process controls were within spec.The pt's medical records were received and a clinical investigation will be completed.Upon the completion of a clinical investigation, a supplemental report will be submitted.

• 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: jacqueline kramer ; 920 winter st; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4647978
• MDR Text Key: 5595215
• Report Number: 2937457-2015-00413
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• 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?: Yes
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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: PD SOLUTIONS,; LIBERTY CYCLER SET,
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 63 YR
• Patient Weight: 85