MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-07 for HARVEST TERUMO 51422 manufactured by Terumo Bct.
[90055681]
Additional product code: fmf investigation: the harvest disposable set was unavailable for return and investigation. The harvest disposable set contain multiple components that have various expiry dates. The outer set label contains the expiry date associated with the component that has the shortest expiry timeframe. Based on the information stated on the shipping slip, the use of an expired set was confirmed. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[90055682]
Upon review of the information provided by the distributor, it was discovered that an expired bone marrow aspirate concentrate (bmac) disposable was used on a patient. The bmac disposable set was labeled with an expiration date of 09/01/2017. The blood was processed and the bmac product was administered to the patient on (b)(6) 2017. Patient? S information is not available at this time. Patient outcome is not available at this time. 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 | 1722028-2017-00392 |
| MDR Report Key | 6926614 |
| Date Received | 2017-10-07 |
| Date of Report | 2017-10-06 |
| Date of Event | 2017-09-11 |
| Date Mfgr Received | 2017-11-10 |
| Device Manufacturer Date | 2016-10-01 |
| Date Added to Maude | 2017-10-07 |
| 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 | 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 | 0 |
| Brand Name | HARVEST TERUMO |
| Generic Name | BMAC2 60-01, BONE MARROW ASPIRATE CONCENTRATE PROCEDUR |
| Product Code | JQC |
| Date Received | 2017-10-07 |
| Catalog Number | 51422 |
| Lot Number | 10Z9935 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-10-07 |