MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-30 for 3ME-SC203A TSCDII 110V 3MESC203A manufactured by Terumo Bct.
[85779673]
Investigation: the customer stated that while using the sealer device, the wafer cartridge was not loaded correctly resulting in multiple welds from the single-use wafer. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[85779674]
The customer reported that post red blood cell (rbc) procedure, a lab technician was processing a unit of neonatal aliquot with the collected product. While the technician was processing the neonatal aliquot, it was discovered that multiple welds were made from the single-use wafer. The customer is alleging a possible microbial contamination of the product. The customer stated that a patient was transfused with the neonatal aliquot, however, specific dates of the rbc transfusion is not available at this time and it is unknown at this time if medical intervention was required for this event. Per the customer, the rbc products were collected on (b)(6) 2017 and lab processing was performed on (b)(6) 2017. Donor unit #: (b)(6). The customer declined to provide the patient weight and outcome.
Patient Sequence No: 1, Text Type: D, B5
[119219533]
Investigation: terumo bct performed a use testing using a tscdii welder and was able to duplicate the reported condition. During the testing, two simultaneous evaluations were made. The first simultaneous evaluation was an issue of the cartridge switch. It was noted that if the switch senses that a wafer is in place, it will proceed to weld if there is no wafer present. This can occur if the cartridge is misloaded. The 2nd simultaneous evaluation was observed during the resistance check of the wafer. After performing a weld, the resistance of the wafer is changed and is checked to ensure a new wafer has been advanced. If the resistance check fails, the single-use wafer can be reused without the machine alarming. No additional complaints have been received for this device regarding the reported condition. A review of the last year of service history for this device indicated no other reports related to this issue. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722028-2017-00362 |
| MDR Report Key | 6832721 |
| Date Received | 2017-08-30 |
| Date of Report | 2017-08-30 |
| Date of Event | 2017-08-06 |
| Date Mfgr Received | 2018-03-14 |
| Device Manufacturer Date | 2017-02-03 |
| Date Added to Maude | 2017-08-30 |
| 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 | 3ME-SC203A TSCDII 110V |
| Generic Name | TSCDII 110V |
| Product Code | KSB |
| Date Received | 2017-08-30 |
| Model Number | 3MESC203A |
| ID Number | 05020583300033 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-08-30 |