MAUDE Adverse Event Report: CAREFUSION INSPIRATORY LINE PED HTD 6FT 20/CS; HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER

Model Number RC60002081

Device Problem Device Slipped (1584)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/01/2014

Event Type  Injury  

Event Description

Customer reported in (b)(4): we have had an increasing problem with the temp probes slipping out of the port located near the heater chamber.We currently are using a trach ties to secure this connection.Customer stated that prior to using the trach ties, there was an incident where the desaturated below 60% which required bagging and intervention.There was no long term patient harm.Representative sample to be sent.Additional information received on (b)(4) 2014: customer stated she is using 900mr869 wire adapters.

Manufacturer Narrative

(b)(4).A representative sample was sent to the manufacturing plant.Investigation is in process.Upon carefusion¿s investigation, a follow up medwatch will be submitted.

Manufacturer Narrative

(b)(4).Results of investigation:one representative (closed) sample was received for evaluation.The sample was inspected in accordance with our inspection procedure and no issues were found.In addition, the connector (mr850 ad ire mnfold w port) was dimensionally inspected according to the applicable drawing and no problems were observed.The returned sample was found within specifications.No issues were found during the review of internal production records for the lot indicated that could result in the reported condition.The material components of the connector were dimensionally inspected and component was found within carefusion specification.The manufacturing process review revealed no issues.At this time, carefusion quality personnel perform a sampling of product testing for leakage, along with an incoming inspection to the 22 mm plug is performed with a gauge prior to passing to the next stage.Based on the investigation results, the most probable cause for the issue reported could not be confirmed as the returned sample was found within carefusion specification.As a preventive action, carefusion recommends following the product label for recommended use.The product label states the following: humidifier: mr 850 with wire adapter 900mr801, minimum flow rates 3.0 lpm.Humidifier: mr700, mr720, mr730, hc500 with wire adapter 900mr901, minimum flow rates 1.5 lpm.Carefusion will continue to monitor and trend this report.

• Brand Name: INSPIRATORY LINE PED HTD 6FT 20/CS
• Type of Device: HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
• 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: 3788039
• MDR Text Key: 18542009
• Report Number: 8030673-2014-00114
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: RC60002081
• Device Lot Number: 0000412199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention