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

Catalog Number RTLR180343

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

Patient Problems Chest Pain (1776); Hyperglycemia (1905); Hypoxia (1918); Pulmonary Edema (2020); Sepsis (2067); Respiratory Failure (2484)

Event Date 09/06/2018

Event Type  Injury  

Manufacturer Narrative

There is a temporal relationship between the patient event of chest pain, vomiting and breathing heavily with subsequent hospitalization for pulmonary edema, respiratory failure with hypoxia and sepsis and pd therapy on the liberty select cycler.However, a review of the treatment records for the date of the event does not reveal any iipv event.There is no documentation to show a causal relationship between the adverse event and the liberty select cycler.The patient had a recent hospitalization for pneumonia and has several cardiac issues including being diagnosed with systolic congestive heart failure and chronic hypertension that is documented as causing or contributing to the pulmonary edema.Per the medical records, it was suspected the patient was under dialyzed.Per the initial report, the patient had not utilized the cycler for six days prior to hospitalization, but completed pd therapy with manual exchanges.There was no allegation in the medical records of any machine issues.The causal event for the reported encephalopathy was acute ischemic stroke as shown by several small infarcts which were likely embolic.There is no relationship between pd therapy and the ischemic stroke leading to encephalopathy.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A caregiver for a patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) contacted technical support to request a replacement cycler.The contact stated that the patient was overfilled.The patient was feeling chest pain, was vomiting and breathing heavily after the last treatment (date unspecified).After completing treatment the patient drained an additional 2,500ml of fluid.The patient has been completing manual exchanges since then.A review of treatment data did not show an increased intraperitoneal volume (iipv).Additional information was received from the patient¿s caregiver through email stating that the patient was hospitalized for pneumonia due to overfill.However, follow up with the peritoneal dialysis registered nurse (pdrn) clarified that the patient was hospitalized for pulmonary edema, but pneumonia and fluid overload were ruled out as the cause.Review of medical records documented that the patient was transported via emergency medical services (ems) to the emergency room (er) for difficulty breathing after not feeling well for several days.The patient was noted to have decreased level of consciousness, responding to voice only, and be in respiratory distress.The patient arrived at the er and was placed into critical care room due to the severity of the patient¿s condition.The patient was recently seen for pneumonia and treated with antibiotics.The patient had also complained of abdominal pain and chest pain since discharge from her previous hospitalization 12 days prior.A review of the patient¿s systems found coarse lung sounds throughout, tachycardia and respiratory distress.After pre-oxygenation the patient was intubated to protect the airway.A chest x-ray showed diffuse pulmonary edema as well as a large infiltrate.The patient was diagnosed with severe sepsis with respiratory failure.There were no obvious ekg changes.Concern for an infection in the pd fluid prompted a paracentesis to draw abdominal fluid.Later, culture results would be negative with no growth, no polymorphonuclear leukocytes (pmn), and no organisms seen.It was suspected that the patient likely had both a component of fluid volume overload from under dialysis and pneumonia which required emergent hemodialysis (hd).It was also noted the patient currently had pd fluid in the abdomen which needed to drain.A central line was placed utilizing the right femoral vein.The patient was sent to the intensive care unit (icu), placed on a ventilator for support and started on antibiotics of vancomycin, doxycycline and cefepime (route, dose, frequency and duration unknown) to cover hospital acquired pneumonia.The patient was seen by cardiology to assess for non-st elevation myocardial infarction (nstemi) due to intermittent chest pain and elevated troponin i (peaked at 4.08 the patient¿s blood and sputum cultures came back negative.Additional information received in the discharge summary stated that the edema and respiratory failure was secondary to pneumonia, volume overload and worsening of systolic heart failure.The patient was started on heparin (route, dose, frequency and duration unknown) and plavix was discontinued.Coumadin (route, dose, frequency and duration unknown) was also started and the patient¿s inr was therapeutic level (unknown value) prior to discharge.The patient also complained of difficulty swallowing and was placed on a dysphagia diet after being evaluated by a speech therapist.It was recommended that the patient be discharged to a short-term rehabilitation facility due to weakness and the risk of falls, however, the patient and family refused and the patient was discharged after 10 days to home with outpatient physical therapy.The patient continued with pd therapy during hospitalization after the initial hd treatments, but it is unknown if any fresenius products were utilized.

Manufacturer Narrative

No parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• 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
• 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: 7906335
• MDR Text Key: 121707147
• Report Number: 2937457-2018-02856
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

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 Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 09/25/2018
• Supplement Dates Manufacturer Received: 09/26/2018
• Supplement Dates FDA Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2015
• 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; Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 43