MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-14 for HARVEST TERUMO 51400 manufactured by Terumo Bct.
[185699182]
Investigation: harvest product kits contain multiple components that have various expiry dates. The outer kit label contains the expiry date associated with the component that has the shortest expiry timeframe. A review of the certificate of compliance shows that this lot met all acceptance criteria for release. As the reported adverse event did not relate to activities associated with the manufacture of this lot, further review of the device history record was not performed for this report. Correction: clinical support spoke with the nurse at the facility, the doctor knew prior to the procedure that the set was expired and used the set knowingly. The nurse assured clinical support that there were no more expired sets. Root cause: based on the clinical findings, the use of the expired set was caused by operator error.
Patient Sequence No: 1, Text Type: N, H10
[185699183]
During a conversation between the terumo bct account manager and the doctor at the customer site, the doctor disclosed that they performed a platelet-rich plasma (prp) injection the previous day on a patient with chronic foot pain using an expired set. It was reported that the doctor knew prior to the procedure that the set was expired and used the set knowingly. The patient status is reported as healthy. The disposable set is unavailable for return because it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2020-00065 |
| MDR Report Key | 9711753 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-01-24 |
| Device Manufacturer Date | 2016-05-16 |
| Date Added to Maude | 2020-02-14 |
| 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 |
| Reporter Occupation | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SCOT HILDEN |
| Manufacturer Street | 10810 W COLLINS AVE |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032314970 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARVEST TERUMO |
| Generic Name | PC-30 PLATELET CONC PROCEDURE SET |
| Product Code | ORG |
| Date Received | 2020-02-14 |
| Model Number | 51400 |
| Catalog Number | 51400 |
| Lot Number | 05Z9926 |
| Device Expiration Date | 2017-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-02-14 |