MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-10-31 for HARVEST TERUMO 51421 manufactured by Terumo Bct.
[126664776]
Additional product code: fmf investigation: the disposable set was not available for return. Harvest product kits contain multiple components that have various expiry dates. The outer kit label contains the expiry date associated with the component that has the shortest expiry time frame. The device history record (dhr) for this lot was reviewed to determine the components that would have been expired at the time of use. The following components were past their expiration date:apc 30/60 process tray, exp date: 01/2018 and 12/2017 bmac 30ml collection kit, exp date: 01/2018 filter bag assembly: 11/2017 all other components were within the expiration date at the time of the procedure. Root cause: the root cause of the usage of the expired disposable was human error by the distributor. Correction: the distributor identified the error and understood the error. The customer confirmed terumobct sales representative and physician have been informed as well.
Patient Sequence No: 1, Text Type: N, H10
[126664777]
Upon review of the information provided by the distributor, it was discovered that an expiredbone marrow aspirate concentrate (bmac) disposable was used on a patient. The bmac disposable set was labeled with an expiration date of 11/01/2017. The set was used on (b)(6) 3018. Post procedure for spinal fusion, the customer confirmed that the patient did not develop an infection or experience any adverse events due to the use of the expired bmac set. The customer declined to provide the patient id. The bmac set is not available for return because it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2018-00298 |
| MDR Report Key | 8024834 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-10-31 |
| Date of Report | 2018-10-31 |
| Date of Event | 2018-08-30 |
| Date Mfgr Received | 2018-10-08 |
| Device Manufacturer Date | 2016-12-07 |
| Date Added to Maude | 2018-10-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEVE KERN |
| Manufacturer Street | 10810 W COLLINS AVE |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032392246 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARVEST TERUMO |
| Generic Name | BMAC2-30-02, BONE MARROW ASPIRATE CONCENTRATE PROCEDUR |
| Product Code | JQC |
| Date Received | 2018-10-31 |
| Catalog Number | 51421 |
| Lot Number | 12Z9912 |
| Device Expiration Date | 2017-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO BCT |
| Manufacturer Address | LAKEWOOD CO 80215 US 80215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-31 |