MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number LIBERTY SELECT CYCLER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Congestive Heart Failure (1783); Dyspnea (1816); Edema (1820); High Blood Pressure/ Hypertension (1908); Pneumonia (2011); Pulmonary Edema (2020); Respiratory Failure (2484)

Event Date 05/11/2018

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

During routine follow up on a separate event, a peritoneal dialysis patient reported being hospitalized for fluid in the lungs.The patient was admitted on (b)(6) 2018 and discharged on (b)(6) 2018.There was no allegation of a product malfunction.Additional information was solicited, but unavailable.

Event Description

Discharge summary obtained indicated the patient presented with increasing shortness of breath and a productive cough with green phlegm.Chest x-ray showed interstitial infiltrate or edema.The patient¿s respiratory status worsened requiring intubation and mechanical ventilation; the patient was hypertensive with a blood pressure (bp) of 215/127 which required nitroglycerine drip to bring under control.The patient was admitted in the intensive care unit (icu) and samples from the blood, urine, nasopharynx (np), bronchi and peritoneal fluid were collected for cultures.The patient was fluid overloaded because of inadequate peritoneal dialysis resulting in pulmonary edema.The patient¿s dialysis was adjusted for significant fluid removal and the patient tolerated well.Cultures were negative except for the np culture which was positive for human rhinovirus.The patient¿s status improved and the patient was discharged three days later on (b)(6) 2018.

Manufacturer Narrative

There is a temporal relationship between continuous cycle peritoneal dialysis (ccpd) therapy with the liberty select cycler and the respiratory failure due to fluid overload that resulted in the patient¿s hospitalization.However, it is unlikely that the liberty cycler contributed to the patient¿s pulmonary edema.Acute pulmonary edema is a frequent reason for admission of chronic dialysis patients in the icu, essentially precipitated by infections and man-made errors.There was no allegation of the cycler malfunctioning and no deficiency was alleged.The patient¿s np culture was positive for human rhinovirus and according to the physician, the patient was fluid overload due to inadequate dialysis.The patient also reported a 5 pounds weight gain in one month.The patient¿s dialysis prescription was modified and the patient¿s status improved.The patient was discharged three days later in stable condition.Correction: patient code: removed pneumonia the alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.A serial number search in the complaint system found no complaint issues with the same symptom code within 90 days of the notified date of the alleged event.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7577555
• MDR Text Key: 110338180
• Report Number: 2937457-2018-01613
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K171652
• 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: 06/12/2018

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: LIBERTY SELECT CYCLER
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/07/2018
• Supplement Dates Manufacturer Received: 06/01/2018
• Supplement Dates FDA Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER SET; PD SOLUTION; LIBERTY CYCLER SET; PD SOLUTION
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR