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); Hypervolemia (2664)

Event Date 05/12/2017

Event Type  Injury  

Manufacturer Narrative

A follow up mdr will be submitted upon completion of the plant's investigation adn review of the medical records.

Event Description

A peritoneal dialysis patient's daughter stated that the patient was hospitalized on friday (b)(6) 2017 and released on monday, (b)(6) 2017 which is believed to be due to fluid backing up from her not being fully drained by the cycler resulting ultimately in pneumonia.She stated that she often had to drain manually after treatment to remove additional fluid.She stated that the symptoms which led to the hospitalization where persistent coughing and feeling that her lungs were full.She stated that the patient completed treatments and had no missed treatments during the hospitalization.Medical records were received and are currently under review.

Manufacturer Narrative

Although a temporal relationship exists between fresenius products/ liberty cycler and the pt.Experiencing drain complications during ccpd treatment at home with subsequent development of shortness of breath/cough/hypoxia requiring hospitalization for fluid volume overload (hypervolemia) and pneumonia; there is no documentation that indicates a causal relationship between fresenius products and the pt¿s adverse events.In the complaint file, it was noted the pt.Borrowed a cycler from the pd clinic and also received a replacement cycler and the drain complications during ccpd therapy persisted.Furthermore, while the pt.Was noted to be on diuretic therapy at home (adherence unknown), the pt.Was discharged from the hospital on an increased maintenance dose of furosemide (lasix) for optimum fluid management in conjunction with ccpd therapy with adjusted dialysate strengths.Based on the potential multi-factorial causes for fluid overload/pneumonia, actual causality cannot be determined.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 nonconformances during the manufacturing process.

Event Description

Medical records were received and reviewed.The patient presented in the emergency room experiencing shortness of breath with hypoxia and cough.Initial vital signs/evaluation in emergency room are unknown.However it was noted on the medical records the patient received intravenous lasix in the emergency room.The patient subsequently underwent a chest x-ray which revealed the presence of a left lower lobe infiltrate.The patient admitted to the hospital for medical management of intravascular volume overload and community acquired pneumonia.During hospital course, the patient received extra ultrafiltration for 2 nights.Furthermore, the patient was restarted on lasix.The patient was also treated with levaquin for community acquired pneumonia.Cardiology was also consulted and the patient underwent an echocardiogram indicating mild to moderate mitral regurgitation with moderate mitral stenosis and a moderate size apical/ left ventricular aneurysm.At some point during hospitalization, the patient was started on low dose ace inhibitor likely for hypertension potentially exacerbated by intravascular overload.However, upon hospital discharge the patient was noted to be discontinued from the ace inhibitor therapy due to a history of low blood pressure.

• 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: 6693719
• MDR Text Key: 79288416
• Report Number: 2937457-2017-00556
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• 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
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• 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?: No
• Device Age: MO
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2012
• 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 TUBING
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 85