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

Catalog Number RTLR1801

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Hematuria (2558); Weight Changes (2607)

Event Date 04/13/2015

Event Type  Injury  

Event Description

Medical records received from the pt's treatment facility showed a peritoneal dialysis (pd) pt was hospitalization for hematuria, hemorrhagic prostatitis and a nstemi (non-st segment elevation myocardial infarction).The pt was treated with drug-eluding stents in his coronary arteries.The pt was discharged on (b)(6) 2015.This pt is a (b)(6) male who was admitted into the hosp on (b)(6) 2015 with gross hematuria and hemorrhagic prostatitis, as well as non-st segment elevation myocardial infarction (nstemi).During his hospitalization he had a cardiac catheterization and required a stent placement to the right coronary artery.He was not able to tolerate a sent to the left anterior descending coronary artery.The pt was found to be over 20 pounds above his dry weight while hospitalized.He was discharged and his fluid overload was managed outpatient.His weight decreased over 10 pounds, however, he was not progressing.This required further hospitalization for temporary hemodialysis.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant investigation.The pt had an admission on (b)(6) 2015 due to gross hematuria and was found to have hemorrhagic prostatitis as well as non-st segment elevation myocardial infarction (nstemi).At that time he had a stent placement to the right coronary artery (rca).The placement was discharged on an unk date.According to the peritoneal dialysis registered nurse (pdrn), the pt was on a cycler up until their hosp admission on (b)(6) 2015.The pdrn stated the pt was in (b)(6) hosp where they were on a cycler that did not properly drain the pt, which created a fluid overload.The (b)(6) 2015 admitting diagnoses from the medical record do not include fluid overload.There is no documentation in the medical record that shows any causal relationship between the pt's liberty cycler or delflex solution and the pt's fluid overload.Medical records do indicate that the original complaint of the fluid overload occurred while hospitalized (b)(6) 2015.Medical records do not contain any treatment/medical records, progress notes, dialysis flow records, lab/diagnosis tests from the (b)(6) 2015 hospitalizations for review.

• 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 st; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4849869
• MDR Text Key: 5943568
• Report Number: 2937457-2015-01186
• 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: Consumer,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR1801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2011
• 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: LIPITOR 20 MG; PLAVIX 75 MG; CALCITROL 0.25 MG; EPOETIN 5000UNITS; ZEMPLAR; ASPIRIN; ALLEGRA; TAMSULOSIN; PROSCAR; LOPRESSOR; LORETADINE; CALCITRIOL; MULTIVITAMIN 1 TAB; SENSA 1 TAB; PROTONIX; FISH OIL; METOPROLOL; LISINOPRIL 40 MG; LIBERTY CYCLER; COLACE 100 MG; PROSCAR 5 MG DAILY; FLOMAX 0.4; GENTAMICIN 0.1 CREAM APPLICATION TOPICAL DAILY; LORATADINE; COREG; RENVELA 1600 MG; LASIX; ALLOPURINOL 100 MG DIALY; TAMSULOSIN TARTRATE 50 MG; FUMOTIDINE 20 MG; LIBERTY CYCLER CASSETTE; SENSIPAR
• Patient Outcome(s): Hospitalization
• Patient Age: 77 YR