MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-29 for HARVEST TERUMO 51401 manufactured by Terumo Bct.
[89529040]
Investigation: an unused harvest terumo platelet concentrate procedure pack was returnedfor investigation. Upon visual inspection, it was noted that the expiration date on the outsitde label of the set is confirmed to read 2017-08. The expiration date of the label on the lower packaging tray (plasma products pack) is confirmed to read 2016-07. Ac expiration date isconfirmed to read 2016-07. Harvest product set contain multiple components that have various expiry dates. The outer kitlabel contains the expiry date associated with the component that has the shortest expirytimeframe. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[89529041]
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 07/2016. The pack's outer set was labeled with an expiry date of 08/2017. No patient (donor) was connected at the time of the event. No patient (donor) information isreasonably known.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2017-00383 |
| MDR Report Key | 6906198 |
| Date Received | 2017-09-29 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-09-07 |
| Date Mfgr Received | 2018-05-14 |
| Device Manufacturer Date | 2014-09-26 |
| Date Added to Maude | 2017-09-29 |
| 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 | PC-60 PLATELET CONC PRODECURE PACK |
| Product Code | ORG |
| Date Received | 2017-09-29 |
| Returned To Mfg | 2017-09-16 |
| Catalog Number | 51401 |
| Lot Number | 503985 |
| ID Number | 05020583514010 |
| Device Expiration Date | 2016-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-09-29 |