MAUDE Adverse Event Report: PARI RESPIRATORY EQUIPMENT, INC. PARI E-RAPID NEBULIZER; NEBULIZER (DIRECT PATIENT INTERFACE)

Lot Number SKU P178G1030

Device Problems Defective Component (2292); Inaccurate Delivery (2339)

Patient Problem Underdose (2542)

Event Date 07/19/2019

Event Type  malfunction  

Event Description

The pari respiratory company sells a nebulizer that is 15 times more expensive than the basic nebulizer because of the speed in which it distributes tobramycin mist to pts.However, there is a flaw.The equipment does not turn 1 ml to mist, thus preventing pts from receiving the full 300 mg of tobramycin.Pts are undermedicated.I use a nebulizer because i have bronchiectasis with a colonization of pseudomonas bacteria.At first i used the standard park vios nebulizer for bethkis at (b)(6), then paid 15 times as much for the pari e-rapid nebulizer ((b)(6) on sale), which cuts the treatment time in half.After using it since the purchase date of 04/21/2019 i became concerned that the equipment regularly was unable to convert all 4 ml of 300mg bethkis (generic tobi, or tobramycin) to mist the dme always left one ml behind, to be discarded.The 300mg is the standard dose, which i was prescribed by my pulmonologist, dr.(b)(6).In order to get the 300 mg, a patient would need to inhale all 4 ml.With the expensive e-rapid, a patient can get only 225 mg, which is unacceptable.A vice president of genericus, a company that distributes a formulation of generic tobi (b)(4) which requires a patient to inhale 5 ml of medication to absorb the needed 300 mg, informed me that the pari e-rapid nebulizer deliberately retains 1 ml to avoid over-medicating the patient.Really? sounds like a defect to me.Again: one needs to inhale all four milliliters of bethkis to get the needed 300 mg, and in fact needs to inhale five milliliters of genericus company's tobramycin to get the 300mg.The company may try to tell you that the discard of 1 ml is intentional.This is absurd given the above information.The problem is that patients who are unaware of this flaw in the expensive e-rapid are, like me, being shortchanged of the medication they need to fight the colonization of bacteria.Given this defect in all pari e-rapid nebulizers, i sent mine back for a refund to pari respiratory (804) 253-7274, 2412 park way, midlothian va 23112.Potential customers of the e-rapid are spending fifteen times what they should spend for a product that is defective.If they continue using it with the assumption that it works against the bacteria colonization, they will be shortchanged.The pari e-rapid nebulizer should be taken off the market and manufactured without the flaw.If this is not possible, the pari e-rapid nebulizer should not be sold to an unsuspecting public.

• Brand Name: PARI E-RAPID NEBULIZER
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 8842623
• MDR Text Key: 153276932
• Report Number: MW5088493
• Device Sequence Number: 1
• Product Code: CAF
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: SKU P178G1030
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 56