MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-01-05 for HARVEST TERUMO 51408 manufactured by Terumo Bct.
[97726512]
Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[97726513]
Upon review of the information provided by the distributor, it was discovered that an expired autologous platelet concentrate (apc) disposable was used on a patient. The apc disposable set was labeled with an expiration date of 01/01/2017. The blood was processed and the apc product was administered to the patient on (b)(6) 2017. Patient's full identifier: (b)(6) the customer declined to provide patient's weight and outcome. The apc set is not available for return because it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2018-00004 |
| MDR Report Key | 7167959 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-01-05 |
| Date of Report | 2018-01-05 |
| Date of Event | 2017-12-11 |
| Date Mfgr Received | 2018-09-18 |
| Device Manufacturer Date | 2016-04-19 |
| Date Added to Maude | 2018-01-05 |
| 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 | APC-120 PROCEDURE PACK |
| Product Code | ORG |
| Date Received | 2018-01-05 |
| Catalog Number | 51408 |
| Lot Number | 04Z9915 |
| ID Number | 05020583514089 |
| Device Expiration Date | 2017-01-01 |
| 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 | 2018-01-05 |