MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE LIBERTY CYCLER SET, SINGLE PATIENT CONN

Model Number 050-87215

Device Problems Invalid Sensing (2293); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems High Blood Pressure/ Hypertension (1908); Seizures (2063)

Event Date 05/16/2015

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) pt reported that she had convolutions while in treatment during drain zero and contacted 911.The pt stated that she did not know if the convolutions were cycler related.The following is based on the medical records received from the pt's treatment facility.The pt presented to the emergency department with two acute seizure episodes earlier in the day.The pt was confused and not able to give a good history.The pt was able to state she had a headache earlier in the day and had a seizure that resolved spontaneously.While she was enroute to the hospital she had a generalized seizure that also resolved spontaneously.The pt was severely hypertensive with systolic blood pressure of 227.The acute seizures were considered to be likely secondary to the hypertensive emergency, but posterior reversible encephalopathy syndrome needs to be ruled out.The pt was able to do alternative treatment at the hospital.On (b)(6) 2015 vitals: blood pressure 226/98, pulse rate 76 beats per minute, respiratory rate: 24 breaths per minute, oxygen saturation: 90 percent on room air.

Manufacturer Narrative

This report is being submitted as part of a system level review; which will include an investigation of all potential fresenius products being used at the time of the event.A supplemental report will be submitted upon completion of plant's investigation and clinical investigation of medical records.

Manufacturer Narrative

Device review: the device was not returned to the manufacturer for physical evaluation.The customer was unable to provide the manufacturer with the lot number of the product used in the reported event.As no lot number was provided by the complainant, a record review was performed on each of the lot numbers shipped to the complainant in the three months leading up to the reported event.The record review found 3 lot number shipped to the customer during that time period.The batch production records for these lots were reviewed.The batch records confirmed that released product met specifications, and documented manufacturing process controls were within specification.Per the documented product investigation, there was no indication that the fresenius product caused, contributed to or was a factor in the reported event.Medical records concluding summary of findings as event related to fresenius products(s): on (b)(6) 2015, it was noted that the patient can be discharged from nephrology standpoint.The patient's blood systolic blood pressure was 200 on (b)(6) 2015 and 160 on (b)(6) 2015 not optimally controlled still.Blood pressure medications were being adjusted for this.Based on records the patient's seizures seem 6 if to be related to uncontrolled hypertension not any of fmc products.It is unlikely this event was related to fmc product use.

• Brand Name: LIBERTY CYCLER SET, SINGLE PATIENT CONN
• Manufacturer (Section D): FRESENIUS MEDICAL CARE; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; parque ind reynosa sur, brecha e-99; apartado postal #326; reynosa, tamps CP 8 8780; MX CP 88780
• Manufacturer Contact: tanya taft, rn ; 7816999000
• MDR Report Key: 4861443
• MDR Text Key: 5811396
• Report Number: 8030665-2015-00301
• 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,User Facility,consumer,health prof
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 050-87215
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ASPIRIN; VALSARIAN; DULOXETINE; JANUVIA; WELCHOL; RONAPLEX; BYSTOLIC; METOLAZONE; ATORVACASTAFIN; LIBERTY CYCLER; NIFEDICAL; CLONIDINE; FUROSEMIDE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR