[8149709]
This is in response to your request for additional info regarding the above referenced incident report. For continuity purposes, your question is repeated below with our response: the final results of any failure analysis or lab testing of the device listed in the report (s) including: a complete description of the methodology (ies), an identification of the failure mode (s) and/or mechanism (s) and the associated component (s) involved, any conclusions based on the final failure analysis or lab test results. Response: we were not able to confirm the customer report. The initial medwatch states elevated carboxyhemoglobin; however, when smiths medical contacted the facility, the facility reported that the actual problem was co2 level. The user facility did initially report that samples were sent to an outside lab for investigation; however, they later reported that samples were not sent to an outside lab for testing. The user facility did report they submitted edits to the medwatch report directly to fda to reflect these changes. The supplier of this product, did contact the user facility directly and tried to get a returned sample for their investigation or a portion of a sample in order to perform an eval. According to the supplier, the contact at the facility, doctor, risk mgmt and rep, head of biomedical stated they would not provide a sample for eval. A review of device history and batch records was performed by the supplier and no nonconformances were noted. In addition, retained samples from the lot numbers reported were tested and no nonconformances were identified; the samples tested met the performance standards. What action (s) have you taken to address the reported problem? Response: without a return of the event sample, we were unable to assign a possible root cause for this event. The supplier was contacted to review their device history and batch records, in addition for testing of retained samples, as noted above. The user facility did report that they did continue to use their inventory of sodasorb. No further communications have been received from the user facility by smiths medical or facility. How many complaints have you received for the reported problem? Response: this is the only complaint report of this type which was received, for this product line, within the past seven years.
Patient Sequence No: 1, Text Type: N, H10