MAUDE Adverse Event Report: PRESSURIZED ELASTOMERIC INFUSION DEVICE; PUMP, INFUSION, ELASTOMERIC

Device Problems Inadequate Instructions for Healthcare Professional (1319); Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Adult Respiratory Distress Syndrome (1696); Dyspnea (1816); Pulmonary Edema (2020); Diaphoresis (2452); Low Oxygen Saturation (2477); Heart Failure/Congestive Heart Failure (4446)

Event Date 06/30/2021

Event Type  Injury  

Event Description

I developed sepsis from shoulder surgery and was treated in hospital for 13 days.My treatment plan was to continue antibiotic treatment with cefazolin by iv for 6 weeks.I requested in home service.The only option i was given for in home treatment was through paragon infusion care, inc.Paragon uses a self administered, pressurized elastomeric devise which delivers 20ml per hour over a 24 hour period.Weekly visits and monitoring were done through a home health care provider.Approximately one week after starting treatment using paragon's system, i was transported to the hospital by ambulance in respiratory distress.This resulted in another 7 day stay in hospital and prompted tens of thousands of dollars of testing including echocardiogram only to determine my heart function was sufficient and there was a need for diuresis with the pressurized infusion.Diuresis quickly remedied my problems.I continued with the paragon system infusion while in hospital these 7 days.I was given a ten day supply of lasix by a cardiologist and given an appointment for 12 days from that date.I took my last 20mg lasix on saturday (b)(6).Monday, (b)(6), i saw the infectious disease doctor, who in her assessment noted heavy congestion when assessing breath sounds but did not ask additional questions.My cardiologist appointment was to be the following day.Approx 1:00 am tuesday morning i woke up and could not breath.I was in acute respiratory distress.According to my husband (a retired paramedic) my pupils were fully dilated, i was wet with sweat from either diaphoresis, or work of trying to expand my lungs.I was near to going into cardiac arrest.The pulse oximeter showed my oxygen saturation at 29% when read by fire department personnel.I was fortunate to get a rapid emergency response and qualified prehospital care to save my life.My husband believes that if i had become unresponsive that they would not have saved me.The er doctor again quickly recognized the problem was caused not continuing diuresis.I spent three days in icu at an atlanta hospital and quickly recovered.This hospital did not continue using the elastomeric device, but supplied and administered their own cefazolin daily dose.When they released me, they were about to send me home without a prescription for lasix again although i was to continue treatment with the paragon system.To bring this to a conclusion, the continual infusion from paragon's pressurized device appears to have caused pulmonary edema and chf that i did not experience when receiving daily infusions over a short period of time using the normal gravity flow method.Specialization among medical providers and the lack of communication between them as well as inadequate instruction to providers as to the possible complications of using paragon's self administered infusion created a danger in this case.Without myself and others recognizing or understanding the problem and notifying paragon or the fda, lives may be lost.All medical records and treatments can be obtained and provided.Fda safety report id # (b)(4).

• Brand Name: PRESSURIZED ELASTOMERIC INFUSION DEVICE
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• MDR Report Key: 12967581
• MDR Text Key: 282049846
• Report Number: MW5105940
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: B12; BENAZAPRIL ; GLIMEPERIDE ; METHADONE; MULTI-VITAMIN ; OXICODONE; PAXIL ; VITAMIN D
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White