MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2010-03-02 for A200SP ABSORBER manufactured by Penlon Ltd..
[1457630]
It was reported that a (b) (6) man died after an emergency craniectomy following a road traffic accident at the (b) (6) trauma centre, (b) (6). A routine check of the a200sp absorber was carried out prior to the use. The patient's vital signs were being monitored and were within normal limits. Twenty minutes later, the fico2 increased from 0 to 15mmgh and etco2 increased from 34 to 50mmhg. The soda lime in the canister had not changed color and the unidirectional valves were functioning normally. The flows were then increased and manual ventilation was initiated. On closer inspection of canister, one of the three rubber spacers on which the inner chamber of the soda lime canister is seated was found to be missing. As a consequence the patient had been rebreathing co2. Once the spacer was replaced the fico2 and etco2 normalized. The hospital acknowledged the missing spacer was probably been due to human error when the canister was cleaned or refilled with soda lime. The instructions for use for this device state the user should check the three spacers are in place before use. Our distributor has confirmed that they provided training for the staff at the hospital. The hospital do not wish to return the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610531-2010-00001 |
| MDR Report Key | 1619837 |
| Report Source | 01 |
| Date Received | 2010-03-02 |
| Date of Report | 2010-01-03 |
| Date Mfgr Received | 2010-01-29 |
| Date Added to Maude | 2010-03-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANGELA DUNFORD, MANAGER |
| Manufacturer Street | BARTON LANE ABINGDON BUSINESS PARK |
| Manufacturer City | ABINGDON OX143PH |
| Manufacturer Country | UK |
| Manufacturer Postal | OX14 3PH |
| Manufacturer Phone | 235547000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | A200SP ABSORBER |
| Generic Name | ABSORBER CARBON DIOXIDE |
| Product Code | BSF |
| Date Received | 2010-03-02 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PENLON LTD. |
| Manufacturer Address | BARTON RD ABINGDON BUSINESS PARK ABINGDON OX143PH UK OX14 3PH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2010-03-02 |