MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2009-12-03 for QUIXIL APPLICATION DEVICE manufactured by Omrix Biopharmaceuticals Ltd..
[1254458]
A serious spontaneous report regarding a male pt of unk age, who was reported to have died on an unk date. The pt had received treatment with quixil. The case was reported by a physician via a sales rep. No concomitant medication or medical history of the pt was reported. The therapy dates, dosing and the clinical course concerning the administration of quixil and the pt's cause of death was not reported. The reporter stated that the pt died a week ago. The reporter did not provide a causality assessment. The company physician assessed the causality as unk. Follow-up info is being requested from the reporter. On 11/18/2009, follow up info was received by the company from the reporter. Additional info was also received 11/20/2009, via a telephone call to the company from the reporter. In 2009, the pt was undergoing an arthroscopy in preparation for an autologous chondrocyte implantation (aci). The knee cavity had been washed during this procedure, and the treating surgeon used the quixil device to direct air into the cavity to dry it. According to the surgeon , air was coming out of the knee during the drying procedure. The surgeon stated quixil had not been administered and that he had created a small defect in the collagen membrane to receive the aci. The surgeon stated that it was important that the pt's own blood was present in the clot to ensure the pt's own stem cells were present to assist in taking the aci correctly. It was during this drying procedure, using the quixil device, that the pt deteriorated and died. A postmortem showed air embolism. The surgeon also stated that he had been prepared to administer quixil if there had been bleeding, requiring control and was also planning to use quixil to help hold the aci in place. The causality of the event of fatal air embolism with the quixil device was not reported.
Patient Sequence No: 1, Text Type: D, B5
[8344303]
The company physician considered the event of fatal air embolism to be not related to the drug quixil, as this was not used in the entire procedure. This was a case of device misuse, as the quixil device is not intended for applying air, and hence, used off-label. The 35 cm tip; modular device 1, 2ml; modular device 5 ml; two pressure regulators.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003183625-2009-00078 |
| MDR Report Key | 1561922 |
| Report Source | 01,05,06,07 |
| Date Received | 2009-12-03 |
| Date of Report | 2009-11-27 |
| Date of Event | 2009-10-20 |
| Date Mfgr Received | 2009-11-18 |
| Date Added to Maude | 2009-12-23 |
| 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 Street | M.D.A. BLOOD BANK SHEBA HOSPITAL |
| Manufacturer City | RAMAT GAN 52621 |
| Manufacturer Country | IS |
| Manufacturer Postal | 52621 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUIXIL APPLICATION DEVICE |
| Generic Name | PRESSURE REGULATOR DEVICE |
| Product Code | NKK |
| Date Received | 2009-12-03 |
| ID Number | (MDD CLASS IIA |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OMRIX BIOPHARMACEUTICALS LTD. |
| Manufacturer Address | M.D.A. BLOOD BANK SHEBA HOSPITAL RAMAT GAN 52621 IS 52621 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2009-12-03 |