MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-17 for HARVEST TERUMO 51401 manufactured by Terumo Bct.
[106146999]
Investigation: per customer, the specified amount of acda anticoagulant recommended asper the manufacturer? S instructions was added to the product. After the centrifugation, more acda was added to the product. However, the addition of more acda anticoagulant did not correct the clotting in the product. The customer stated that the patient was undergoing a hair restoration procedure. Terumo bct customer support followed up with the customer for this event and the customer reported that the use of the expired set was the result of operator error. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[106147000]
The customer initially called to report that a during a platelet rich plasma (prp) procedure on a patient, the processed prp product clotted off completely during centrifugation. Later,upon review of the information provided by the customer, it was discovered that an expired platelet concentrate disposable set was used on the patient. The disposable set was labeled with an expiration date of 06/01/2017. The procedure was performed on (b)(6) 2018. Per the customer, the blood was collected and processed, but not administered to the patient. The customer reported that the patient is in healthy condition. Patient weight is 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 | 1722028-2018-00099 |
| MDR Report Key | 7436429 |
| Date Received | 2018-04-17 |
| Date of Report | 2018-04-17 |
| Date of Event | 2018-03-06 |
| Date Mfgr Received | 2018-07-16 |
| Device Manufacturer Date | 2016-07-14 |
| Date Added to Maude | 2018-04-17 |
| 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 PROCEDURE SET |
| Product Code | ORG |
| Date Received | 2018-04-17 |
| Catalog Number | 51401 |
| Lot Number | 07Z9925 |
| ID Number | 05020583514010 |
| Device Expiration Date | 2017-06-01 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-17 |