MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,foreign,health professi report with the FDA on 2015-04-21 for HARVEST TERUMO APC20I manufactured by Terumo Bct.
[5666837]
The customer reported that after opening a harvest terumo platelet concentrate procedure pack, it was noticed that the expiry date on the label of a bottle of anti-coagulant (ac) was 02/2015. The pack's outer carton was labeled with an expiry date of 2016. The customer had two further packs with the same expiry dates on the ac and the carton in their inventory. The packs were not used. The disposable pack is not available for return because it was discarded by the customer. Due to eu personal data protection laws, the patient information is not available from the customer.
Patient Sequence No: 1, Text Type: D, B5
[13243097]
Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[29923701]
Investigation: the disposable sets were unavailable for return for analysis. It is possible that the customer discarded the original outer packaging which contains the set expiry information. Root cause: a definitive root cause could not be determined. The disposable set was unavailable for return and root cause investigation. It is possible that the outer kit packaging was discarded, prior to use, which contained the correct kit expiry information, based on the shortest component expiration date.
Patient Sequence No: 1, Text Type: N, H10
[50864107]
This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722028-2015-00149 |
| MDR Report Key | 4714193 |
| Report Source | 01,05,FOREIGN,HEALTH PROFESSI |
| Date Received | 2015-04-21 |
| Date of Report | 2015-03-27 |
| Date of Event | 2015-03-27 |
| Date Mfgr Received | 2016-07-29 |
| Date Added to Maude | 2015-04-22 |
| 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 | GLENDA O'NEILL |
| Manufacturer Street | 10811 W. COLLINS AVE |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032314051 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARVEST TERUMO |
| Generic Name | AUTOLOGOUS PLATELET CONCENTRATE PROCEDURE PACK |
| Product Code | ORG |
| Date Received | 2015-04-21 |
| Catalog Number | APC20I |
| Lot Number | 609654 |
| 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 | 2015-04-21 |