MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-05 for HARVEST TERUMO APC30 manufactured by Terumo Bct.
[38160633]
Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[38160634]
The customer reported that her kit was not decanting well. While troubleshooting, she discovered that the anticoagulant had expired in the kit that she had used. The customer was unable to provide lot number or expiration date of the anticoagulant that was used. The customer was able to withdraw viable platelets from the product and was able to use them for the treatment. Patient information is not available at this time. The kit is not available for return, because it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
[39594933]
Investigation: the disposable sets were unavailable for return for analysis. 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 time frame. Based on the information provided by the customer the anticoagulant used during the procedure was expired. The customer was not able to provide the kit lot number, anticoagulant bottle lot number, nor the anticoagulant bottle expiration date. Root cause: a definitive root cause could not be identified as it could not be determined why expired product was available at the customer site. 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. Individual component expiry labeling is present to ensure usage prior to expired dates. The device history record for this product showed all product passed quality labs and sterilization requirements.
Patient Sequence No: 1, Text Type: N, H10
[39594934]
No medical intervention was needed for this event. T he customer did not provide the patient's information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2016-00043 |
| MDR Report Key | 5413746 |
| Date Received | 2016-02-05 |
| Date of Report | 2016-02-05 |
| Date of Event | 2016-01-08 |
| Date Mfgr Received | 2016-02-24 |
| Date Added to Maude | 2016-02-05 |
| 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 | MATTHEW BICKFORD |
| Manufacturer Street | 10810 W COLLINS AVE |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032052494 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARVEST TERUMO |
| Generic Name | APC30 PLATELET PROCEDURE PACK |
| Product Code | ORG |
| Date Received | 2016-02-05 |
| Catalog Number | APC30 |
| 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 | 2016-02-05 |