MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-06 for ACDA 750ML, U.S. 40800 manufactured by Terumo Bct, Ltd.
[113871843]
(b)(4). Investigation: per the customer, the operator noticed that acda was expired before connecting the patient. The customer stated that they replaced the bag of expired acda with aacda bag that was within the expiration dates and reprimed the machine before connecting. The investigation is in-process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[113871844]
The customer reported that during a mononuclear cell (mnc) collection procedure on anamicus machine, an expired bag of terumo bct, ltd anticoagulant citrate dextrose solution, solution a (acda) was used on a patient. The anticoagulant citrate dextrose solution a (acda) bag was labeled with an expiration date of 05/01/2018. The procedure was performed and the acda was administered to the patient on (b)(6) 2018. It is unknown at this time if medical intervention was required for this event. The customer did not respond to multiple attempts to obtain information for the investigation such as procedural details, patient information, and lot information. Patient outcome is not available at this time. The acda bag is not available for return because it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001980567-2018-00001 |
| MDR Report Key | 7666039 |
| Date Received | 2018-07-06 |
| Date of Report | 2018-07-06 |
| Date of Event | 2018-06-11 |
| Date Facility Aware | 2018-06-11 |
| Date Mfgr Received | 2018-10-10 |
| Date Added to Maude | 2018-07-06 |
| 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 | ACDA 750ML, U.S. |
| Generic Name | ANTICOAGULANT CITRATE DEXTROSE, SOLUTION A (ACD-A) |
| Product Code | KSB |
| Date Received | 2018-07-06 |
| Catalog Number | 40800 |
| 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, LTD |
| Manufacturer Address | LARNE UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-06 |