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

Model Number LIB

Device Problem Failure to Cycle (1142)

Patient Problem Hypovolemia (2243)

Event Date 03/18/2012

Event Type  Injury  

Event Description

A peritoneal dialysis patient called fresenius technical support regarding an m-21-10 invalid sensor reading in drain 0 of treatment.The patient was connected and had drained 71/50 mls on the cycler.The patient said he was expecting to drain about 2200 mls due to a manual fill earlier in the day.The patient stated he just got out of the hospital this afternoon.According to the patient the hospital visit is due to a combination of heart and dialysis issues.The patient rebooted the cycler but was unable to resume treatment.The patient is unable to re-set up the cycler because he does not have any extra 1.5 percent dextrose bags which are what the doctor advised him to use tonight.Technical support replaced the cycler.

Manufacturer Narrative

A product investigation was performed for this device.A visual inspection showed no physical exterior discrepancies.The reported m21-10 symptom was confirmed due to worn pump motor.A review of the device history record was performed.There were no unexpected variances, adjustments or comments noted in the device record.A review of the complaint or comments noted in the device record.A review of the complaint tracking system listed no other complaints of this symptom for this device.A review was performed by the post market clinical department.Per the pharmacovigilance physician, the event of hypovolemic and cardiogenic shock is unlikely related to the liberty cycler machine.The patient has a history of severe cardiac disease including hypertension.The event might have resulted from a dialysis prescription not adjusted to the patients current condition and also due to low blood pressure.The patient pd plan was adjusted adn his blood pressure medications have been put on hold.There was a problem reported on the cycler after hospitalization.The continuous cycle peritoneal dialysis.

• Brand Name: FRESENIUS LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CM 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4249704
• MDR Text Key: 5110593
• Report Number: 2937457-2014-03093
• 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
• Type of Report: Initial
• Report Date: 03/18/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: RTLR180020
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/12/2012
• Initial Date FDA Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 52 YR
• Patient Weight: 98