MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180111

Device Problem Device Handling Problem (3265)

Patient Problem Peritonitis (2252)

Event Date 12/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The peritonitis was related to technique failure and not peritoneal dialysis with fresenius products.The plant has not completed the evaluation, a follow up will be submitted when the evaluation is complete.

Event Description

The patient¿s nurse reported the patient¿s peritoneal fluid was positive for an aerobic organism and an order was prescribed for vancomycin 1 gram intraperitoneal to go in the manual bag and let dwell for six hours.The patient had reported effluent was very cloudy and experiencing abdominal pain.The patient stated that the multiple tubing segment (mts) set, that patient used had come off.The patient forgot to connect to a new connector and re-connected with the old connection.Patient was prescribed another dose of vancomycin 1 gram intraperitoneal to go in the manual bag and let dwell for six hours.The patient¿s nurse reported on (b)(6) 2016 that the patient¿s peritoneal fluid cell count was wbc 2275, no organisms and no growth.One more order for vancomycin 1 gram was prescribed.

Manufacturer Narrative

The actual device was not returned to the manufacturer for physical evaluation.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device record review confirmed the label reconciliation, result of in-progress, and final qc testing were within specification.

• Brand Name: LIBERTY CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6201111
• MDR Text Key: 63183274
• Report Number: 2937457-2016-01256
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/12/2017

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 Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2014
• 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: CLONIDINE; HYDRALAZINE; LIBERTY CYCLER CASSETTE; LISINOPRIL; MULTIPLE TUBING SEGMENT (MTS) SET; NIFEDIPINE; PD FLUID
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR