MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-09-16 for MEDISORB, MULTI ABSORBER CANISTER 8003138 manufactured by Carefusion Finland Oy.
[54924777]
(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).
Patient Sequence No: 1, Text Type: N, H10
[54924778]
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.
Patient Sequence No: 1, Text Type: D, B5
[60002877]
(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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010838917-2016-00018 |
| MDR Report Key | 5956188 |
| Report Source | OTHER |
| Date Received | 2016-09-16 |
| Date of Report | 2016-11-15 |
| Date of Event | 2016-06-09 |
| Date Mfgr Received | 2016-11-10 |
| Date Added to Maude | 2016-09-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628056 |
| Manufacturer G1 | MOLECULAR PRODUCTS |
| Manufacturer Street | PARKWAY, HARLOW BUSINESS PARK |
| Manufacturer City | HARLOW, ESSEX CM195FR |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CM19 5FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDISORB, MULTI ABSORBER CANISTER |
| Generic Name | ABSORBENT, CARBON-DIOXIDE |
| Product Code | CBL |
| Date Received | 2016-09-16 |
| Model Number | 8003138 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION FINLAND OY |
| Manufacturer Address | HELSINKI FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-09-16 |