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

Catalog Number RTLR180111

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Weakness (2145); Dizziness (2194); Electrolyte Imbalance (2196)

Event Date 07/30/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.

Event Description

A medical support specialist reported that a peritoneal dialysis patient did not receive a replacement cycler and was subsequently admitted to the hospital.The patient came to clinic to borrow clinic cycler and patient was symptomatic and sent to er for weakness and chest pain.Additionally, per the patient's nurse, the patient presented to the hospital with a potassium level of 6.5 meq/l.The patient was dialyzed at the hospital and discharged.The patient has since received a replacement cycler and successfully completing treatments.

Manufacturer Narrative

Date on follow up 1 should be populated as 2017-09-13.Clinical investigation: a temporal relationship exist between waiting for the replacement liberty cycler and the hyperkalemia (high potassium level), weakness and chest pain event resulting in the need to go to the er for a hd treatment for correction of electrolytes levels.However, there is a likely association between the adverse event of hyperkalemia and the patients reported history of non-compliance with dietary intake.The weakness was felt to be related to a calcium deficit in which new medication was prescribed.There was no documentation of chest pain in the hospital discharge summary.At this time there is no documentation in the complaint file supporting a causal association between the liberty cycler and the adverse events causing the patient to present to the hospital.

Manufacturer Narrative

Clinical investigation: a temporal relationship exist between waiting for the replacement liberty cycler and the hyperkalemia (high potassium level), weakness and chest pain event resulting in the need to go to the er for a hd treatment for correction of electrolytes levels.However, there is a likely association between the adverse event of hyperkalemia and the patients reported history of non-compliance with dietary intake.The weakness was felt to be related to a calcium deficit in which new medication was prescribed.There was no documentation of chest pain in the hospital discharge summary.At this time there is no documentation in the complaint file supporting a causal association between the liberty cycler and the adverse events causing the patient to present to the hospital.

Event Description

A medical support specialist reported that a peritoneal dialysis patient did not receive a replacement cycler and was subsequently admitted to the hospital.The patient came to clinic to borrow clinic cycler and patient was symptomatic and sent to er for weakness and chest pain.Additionally, per the patient's nurse, the patient presented to the hospital with a potassium level of 6.5 meq/l.The patient was dialyzed at the hospital and discharged.The patient has since received a replacement cycler and successfully completing treatments.

Event Description

A medical support specialist reported that a peritoneal dialysis patient did not receive a replacement cycler and was subsequently admitted to the hospital.The patient came to clinic to borrow clinic cycler and patient was symptomatic and sent to er for weakness and chest pain.Additionally, per the patient's nurse, the patient presented to the hospital with a potassium level of 6.5 meq/l.The patient was dialyzed at the hospital and discharged.The patient has since received a replacement cycler and successfully completing treatments.

• 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: 6828480
• MDR Text Key: 83936004
• Report Number: 2937457-2017-00806
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 44 YR