MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-10-31 for HEMOLUNG 15.5 FR JUGULAR CATHETER TRAY KIT manufactured by Alung Technologies, Inc.
[125605607]
Alung was notified of a serious deterioration in the state of health which resulted in a medical intervention. The research nurse and doctor were called in immediately from the next door room. After closer inspection they noticed the bleeding was coming from a crack in the ij catheter. Therapy was stopped and the lines clamped. Pressure was applied to the insertion site. The patient became tachycardia and hypotensive and the patient was treated with fluid, blood, and metaraminol. The decision was made to remove line, and direct pressure applied for 30 minutes as per protocol. No evidence of bleeding from insertion site, and there was a suture applied. The patient was monitored for further bleeding per protocol. After closer inspection they noticed the bleeding was coming from a crack in the ij catheter. There was a medical intervention that was required as a result of the blood loss and drop in blood pressure. The patient was given 2 units of blood and drugs to increase his blood pressure due to the loss of blood. On (b)(4) 2018, alung (b)(4) spoke to the research nurse, who confirmed the catheter serial number is (b)(4). The patient remains stable with no further issues related to the issue or sudden end of therapy. (b)(4) informed the research nurse that the explant kit is on its way and an engineer will be downloading the datalog and test the controller when the controller is available. Alung is taking the following actions: continue discussions with the physician and hospital staff to determine if there is any additional information relevant to the case. Alung will collect the controller data log and analyze the system performance during the case therapy. Complete explant analysis of the hemolung catheter. Alung will follow-up or close the case in 30 days. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[125605608]
Alung was notified of a serious deterioration in the state of health which resulted in a medical intervention. After hospital staff rolled the patient they noticed a large amount of bleeding from the insertion site. The research nurse and doctor were called in immediately from the next door room. After closer inspection they noticed the bleeding was coming from a crack in the ij catheter. Therapy was stopped and the lines clamped. Pressure was applied to the insertion site. The patient became tachycardia and hypotensive and the patient was treated with fluid, blood, and metaraminol. The decision was made to remove lin, and direct pressure applied for 30 minutes as per protocol. No evidence of bleeding from insertion site, and there was a suture applied. The patient was monitored for further bleeding per protocol. The catheter has been retained for inspection by alung. The site couldn't remember if the hemolung was alarming due to the emergent situation. The patient is stable after receiving 2 units blood and drugs to increase blood pressure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009763347-2018-00003 |
| MDR Report Key | 8023347 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-10-31 |
| Date of Report | 2018-10-26 |
| Date of Event | 2018-10-19 |
| Date Mfgr Received | 2018-10-19 |
| Device Manufacturer Date | 2017-05-31 |
| Date Added to Maude | 2018-10-31 |
| 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 | MR. FRANK FALCIONE |
| Manufacturer Street | 2500 JANE STREET SUITE 1 |
| Manufacturer City | PITTSBURGH PA 15203 |
| Manufacturer Country | US |
| Manufacturer Postal | 15203 |
| Manufacturer Phone | 4126973370 |
| Manufacturer G1 | ALUNG TECHNOLOGIES, INC |
| Manufacturer Street | 2500 JANE STREET SUITE 1 |
| Manufacturer City | PITTSBURGH PA 15203 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOLUNG 15.5 FR JUGULAR CATHETER TRAY KIT |
| Generic Name | HEMOLUNG CATHETER |
| Product Code | DQR |
| Date Received | 2018-10-31 |
| Returned To Mfg | 2018-12-14 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALUNG TECHNOLOGIES, INC |
| Manufacturer Address | 2500 JANE STREET SUITE 1 PITTSBURGH PA 15203 US 15203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-31 |