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

Catalog Number RTLR180111

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

Patient Problems Pneumonia (2011); Pulmonary Edema (2020); Hypervolemia (2664)

Event Date 02/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4)- the actual device was returned to the manufacturer for physical evaluation.Visual examination found no issues.The simulated treatment was performed and completed without any failures or problems.The weighed and programmed displayed fill values were within tolerance.Physical tests passed.Internal inspection found no issues.The cycler performed as designed and the complaint cannot be confirmed.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 batch record review confirmed the labeling, material, and process controls were within specification.Based on clinical review the patient's flash pulmonary edema was likely related to the fluid overload.The fluid overload was related to missed peritoneal dialysis treatments.The patient's healthcare associated pneumonia was likely related to the hospitalization and compromised respiratory status.

Event Description

A peritoneal dialysis patient's pd nurse (pdrn) reported that the cycler had stopped during treatment.The pd nurse reported that the patient was not responding.The treatment was canceled and the patient was transported to the emergency department of the hospital.Additional information received from the pd nurse confirmed that the patient had experienced fluid overload and flash pulmonary edema.The patient had been admitted to the hospital on (b)(6) 2017 due to fluid overload and flash pulmonary edema.The pd nurse stated that the patient was not completing treatment on the cycler and also was not completing treatments manually.The pd nurse reported that during the hospitalization the patient was intubated and placed on hemodialysis temporarily.Review of the medical records confirmed that the pd patient presented to the hospital with complaints of fatigue and was admitted.The records indicated that the patient had missed peritoneal dialysis treatment sessions due to non-functioning equipment.The patient was initially placed on non-invasive positive pressure for respiratory issues, however, was later intubated on (b)(6) 2017 due to worsening respiratory status.The patient was switched from peritoneal dialysis to hemodialysis during the hospitalization.The patient was diagnosed with acute respiratory failure with hypercapnia and acute pulmonary edema.The patient was treated with antibiotics for healthcare associated pneumonia and later extubated successfully.The patient developed clostridium difficile while hospitalized and was treated eight days with oral antibiotics (vancomycin).The physical examination of the lungs on (b)(6) 2017 revealed that the lungs were clear to auscultation, no wheezes, rales or rhonchi.The patient was discharged home from the hospital on (b)(6) 2017 in stable condition with home healthcare.The patient was re-admitted to the hospital on (b)(6) 2017 for hypoxia related to the healthcare associated pneumonia and discharged on (b)(6) 2017.

• 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: 6444023
• MDR Text Key: 71201126
• Report Number: 2937457-2017-00210
• 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
• Report Date: 03/29/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 03/02/2017
• Initial Date FDA Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2016
• 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: DELFLEX PD SOLUTION; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 104