MAUDE Adverse Event Report: CAREFUSION HUMIDIFIER EMPTY 6 PSI BLUE CAP 50/CS; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number 002006-A

Device Problems Misconnection (1399); Improper or Incorrect Procedure or Method (2017)

Patient Problems Death (1802); Underdose (2542)

Event Date 03/01/2014

Event Type  Death  

Event Description

Customer reported via telephone call: patient's husband didn't thread the cap to the jar correctly, therefore patient died because of no oxygen.  patient died in (b)(6) 2014 patient's lawyer to be in touch with carefusion per (b)(6).  (b)(6) has set up still connected to the concentrator.Additional information received via telephone call from customer ((b)(6)): the issue occurred in (b)(6) 2014 and it wasn¿t till today ((b)(6) 2014) until they visited the home and tested the patient¿s concentrator, as the family initially thought the issue may have been with the concentrator.Phillips respironics concentrator was tested and appeared fine.It was today that the nebulizer was closely observed and appeared misthreaded.The nebulizer bubbled but no oxygen came out. the sample and concentrator are currently with the attorney. per (b)(6), the patient used oxygen nasal cannula between 5-7lpm.Called (b)(6) on (b)(6) 2014 for additional information: series of events: complaint was filed to carefusion on (b)(6) 2014 and according to (b)(6) this was after visiting the patient¿s attorney office where the concentrator with set-up (carefusion fm 2600, carefusion nasal cannula, carefusion 25ft tubing, carefusion nebulizer 02006 and carefusion water trap 001861) was observed already at the patient¿s attorney¿s office.(b)(6) stated that he was present, the patient¿s attorney, along with a phillip¿s respironics representative -(b)(6) stated his name was (b)(6) and two phillips respironics attorneys.  (b)(6) stated that the patient¿s attorney videotaped this visit.Per (b)(6), the concentrator was on upon arrival to the attorney¿s office since the concentrator has to be on at least an hour prior to any testing.Per (b)(6), the patient¿s attorney received the set up exactly as it was at the patient¿s home.  i asked (b)(6) and he stated he doesn¿t know how or when the attorney received the setup from the patient.When the concentrator was on, the liter flow was on at 7lpm.At this time, the philips respironics representative got a jar/beaker of water that happened to be at the attorney¿s office and put the nasal cannula in there to observe any bubbles to verify that oxygen was coming out the nasal cannula.At this time, it was observed that no oxygen was coming out as no bubbles were observed.The philips respironics representative proceeded to remove the nebulizer product code 02006 from the concentrator to perform his diagnostic testing on the concentrator.At the end of the testing, he stated the machine/concentrator works correctly and he screwed the nebulizer (product 02006) back on the concentrator.The phillips respironics representative stated that there must be a problem between the cannula and nebulizer.The patient¿s attorney asked who manufactured the nebulizer and cannula-and (b)(6) stated carefusion.(b)(6) also stated that the threading appeared to be misthreaded between jar and lid of the nebulizer.

Manufacturer Narrative

(b)(4).Results of investigation:unfortunately, no sample was sent for evaluation.Therefore, the reported condition could not be confirmed.A review of the documentation of internal manufacturing device history records could not be reviewed due to no lot number being reported.It was observed that carefusion quality personnel perform a sampling functional (nebulizing) inspection prior to releasing the product.The instruction for use (ifu) states the correct method to use the bubble humidifier and assure a proper function, which specifies that the user should be tighten the cap securely to bottle in order to create an effective seal.In addition, the minimum oxygen source pressure required to actuate the alarm is 7psi.Flow rates of less than 2l/min may affect the audible alarm.Based on the investigation, it¿s not possible to determine a root cause since the sample was not available for evaluation.Carefusion will continue to monitor and trend this issue.

• Brand Name: HUMIDIFIER EMPTY 6 PSI BLUE CAP 50/CS
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V; cerrada via de la produccion; no85parque indust.mexicali iii; mexicali 2160 0; MX 21600
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4102485
• MDR Text Key: 21493803
• Report Number: 8030673-2014-00124
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991484
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 002006-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/20/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death