MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-09-20 for PPL SEALER manufactured by Terumo Bct.
[3009272]
The customer reported that a staff member at the customer site felt a burning sensation to the tip of the middle finger on the left hand. The rf burn was to the hand holding the tubing being sealed. The staff member was not wearing gloves and their hand was approximately 6 inches away from the sealing electrodes. A plastic splash guard was in place. The seal was performed post donation and post removal of needle from the donor. The staff member's hands were reportedly dry patient information is not available at this time. The heat sealer has been sent to our contractor, emg, for investigation. This report is being filed due to insufficient information provided at this time to determine if a malfunction with the potential for death or injury occurred. The extent of the injury is currently unknown.
Patient Sequence No: 1, Text Type: D, B5
[3224151]
The customer declined to provide the patient's age and weight.
Patient Sequence No: 1, Text Type: D, B5
[10148453]
(b)(4). Investigation: the staff member documented that there was what appeared to be plasma residue on the sealer handle. This was cleaned before the tube sealer was sent for investigation. The sealer is now with our contractor emg. Initial reports from emg indicate that they found residue of a spill in the handle, however this was not the hand that received the rf burn. Investigation evaluation and corrective actions are in-process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[10488349]
(b)(4). This report is being filed to provide additional information. Investigation: the sealer was inspected by (b)(6). On inspection, the sealer was operating without fault and no evidence could be found that could contribute to an rf burn. The system was tested for electrical integrity and deemed to be safe and operating as intended by the manufacturer. A small amount of dry fluid residue was found around the head of the sealer however it was determined that it is unlikely that this would have caused an rf burn. The sealer head has been replaced as a precaution and was sent back to terumo (b)(4) for further analysis. Terumo (b)(4) also confirmed that the sealer is operating correctly. Root cause: the root cause could not be definitively determined. Possible root causes include the operator's hands being too close to the sealer head while performing a seal, operating the sealer without the splashguard, fluid present in the electrode area during use, wet or moist tubing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722028-2012-00742 |
| MDR Report Key | 2753277 |
| Report Source | 01,05 |
| Date Received | 2012-09-20 |
| Date of Report | 2012-08-24 |
| Date of Event | 2012-08-20 |
| Date Mfgr Received | 2013-01-29 |
| Date Added to Maude | 2012-09-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. KRISTEN COHEN |
| Manufacturer Street | 10811 W. COLLINS AVE |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032052870 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PPL SEALER |
| Generic Name | PPL SEALER |
| Product Code | KSD |
| Date Received | 2012-09-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO BCT |
| Manufacturer Address | FUJINOMIYA, JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-20 |