MAUDE Adverse Event Report: CAREFUSION FINLAND OY MEDISORB, MULTI ABSORBER CANISTER; ABSORBENT, CARBON-DIOXIDE

Model Number 8003138

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) - actual device discarded by end user, and not available for evaluation.If additional information is received, a follow-up will be submitted.(b)(4).

Event Description

The end user reported: customer stated that they the unit's ventilator has stopped working.Customer stated that the unit passed the daily, but stopped ventilating during a case.The ge healthcare field engineer that serviced the capital equipment connected to this device reported: "no patient harm, injury or death per biomed.Was on patient.Reported problem occur approximate (b)(6) 2016 / 8:30am.Biomed determined that the sodasorb canister had a big crack in it and was replaced onsite by biomed before field engineer arrived to make repair.Sodasorb canister was thrown out.Intervention required: used ambu bag during machine exchange.

Manufacturer Narrative

(b)(4) - no sample was provided for evaluation.All information provided was obtained from the field service engineer.The crack which was found on the canister is likely due to external impact.The impact could have occurred during transportation storage or use.All units are leak tested on the production line and are visually inspected prior to packing in the carton.This type of impact damage would not typically occur when the unit is packed in the carton (it is held securely and protected by top, bottom and side inserts).The unit is shipped in a qualified carton.The lot code for the cracked unit was not provided.However, a design of the carton was reviewed to improve the level of protection provided to product and to reduce the number of cardboard components (molded pulp tray) to reduce the risk of cardboard fiber contamination.This design has now been approved (reference (b)(4)) and the new carton was implemented during feb 2016.

• Brand Name: MEDISORB, MULTI ABSORBER CANISTER
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): CAREFUSION FINLAND OY; helsinki ; FI
• Manufacturer (Section G): MOLECULAR PRODUCTS; parkway, harlow business park; harlow, essex CM19 5FR; UK CM19 5FR
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5956188
• MDR Text Key: 54924777
• Report Number: 3010838917-2016-00018
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 8003138
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/31/2016
• Initial Date FDA Received: 09/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention