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

Catalog Number RTLR180111

Device Problems Device Alarm System (1012); Overfill (2404)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2015

Event Type  malfunction  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the device manufacturer's device evaluation.

Event Description

A continuous cycling peritoneal dialysis (ccpd) patient called technical support stating that he was receiving drain complication, drain line, and scale alarms.A review of the treatment data provided by the patient indicated a large drain 5: 4039ml.The patient felt no discomfort.Treatment data provided by the patient at time of call: drain 0: 818ml.Fill 1: 2203ml drain 1: 2956ml, fill 2: 2203ml drain 2: 2199ml, fill 3: 2203ml drain 3: 1597ml, fill 4: 2203ml drain 4: 1876ml, fill 5: 2203ml drain 5: 4039ml, fill 6: 1437ml no last drain.The reported drain volume of 4039ml was 184% over the expected drain volume which resulted in a reportable device malfunction.Upon follow up with the patient's pd nurse: she stated that she was aware of the drain issues and the large drain.The patient remained asymptomatic during and following the event.There was no serious injury or need for medical intervention.The patient did complete treatments manually while waiting for the replacement cycler.He didn't understand that "alternate" treatment meant manual exchanges, no treatments missed.The patient remains with the ccpd program in stable condition using the replacement cycler.

Manufacturer Narrative

The actual device was returned to the mfr for physical eval: a visual inspection of the returned cycler exterior showed no sign of physical damage.A simulated treatment (weighed vs.Programmed fill comparison) was performed and completed w/o any failures or problems.A simulated treatment was performed and completed w/o any failures or problems.The "as received" load cell value failed.The load cell "as received" value was out of specification, tared load cell.The load cell value and verification were within tolerance.The valve actuation test and system air leak test passed.The pt sensor calibration check passed.An internal inspection found visual evidence of dried fluid on the bottom cover between the pump assembly and display and within the recess of the bottom cover adjacent to the pump.The cause of the observed dried fluid could not be determined.Passed mushroom head check.A device manufacturing record review was conducted and confirmed there were no deviations or non-conformances during the manufacturing process.Product labeling, material, and process controls were within specifications.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): CONCORD PLANT, FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter street; waltham, MA 02451 ; 7816999751
• MDR Report Key: 5284947
• MDR Text Key: 33230366
• Report Number: 2937457-2015-01689
• 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
• Type of Report: Initial,Followup
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Other Device ID Number: 00840861100972
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/25/2015
• Initial Date Manufacturer Received: 11/08/2015
• Initial Date FDA Received: 12/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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