MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-20 for HARVEST TERUMO 51406 manufactured by Terumo Bct.
[90162100]
Investigation: per the customer, the account manager at the customer? S site ensured that there were no more expired platelet concentrate disposable sets stocked at the physician? S office. The customer stated that the patient was undergoing an elective procedure for pain in her left elbow and left lower leg. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[90162101]
The customer reported that an expired platelet concentrate disposable was used on a patient. The platelet concentrate disposable set was labeled with an expiration date of (b)(6) 2017. The blood was processed and the platelet concentrate product was administered to the patient on (b)(6) 2017. It is unknown at this time if medical intervention was required for this event. The patient is reported in healthy condition. Patient? S age and weight are not available at this time. The platelet concentrate set is not available for return because it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2017-00407 |
| MDR Report Key | 6965608 |
| Date Received | 2017-10-20 |
| Date of Report | 2017-10-20 |
| Date of Event | 2017-09-28 |
| Date Mfgr Received | 2018-05-14 |
| Device Manufacturer Date | 2017-09-18 |
| Date Added to Maude | 2017-10-20 |
| 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 PROCEDURE PACK, APC-60 |
| Product Code | ORG |
| Date Received | 2017-10-20 |
| Catalog Number | 51406 |
| Lot Number | 09A9927 |
| ID Number | 05020583514065 |
| Device Expiration Date | 2019-09-01 |
| 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 | 2017-10-20 |