MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-02-23 for PUMP THOPAZ 0790000 manufactured by Medela Ag.
[100833455]
The? Indicated? Leakage? Was? Misinterpreted? By? The? Operator,? Who? Thought? That? The? Patient? Had? A? Leakage.? Because? Of? This,? The? Wound? Was? Reopened. The? Device? Was? Tested? And? It? Passed? Specifications.?? The? Importance? Of? The? Functional? Test? Is? Clearly? Stated? In? The? Instructions? For? Use;? Additionally? There? Is? Instruction? On? How? To? Locate? A? Leakage.
Patient Sequence No: 1, Text Type: N, H10
[100833456]
On? (b)(6) 2018,? (b)(4)reported? To? (b)(4)? That? During? A? Respiratory? Surgery? In? (b)(6)on? (b)(6) 2017,? A? Patient? Had? To? Have? A? Re-opened? Chest? Surgery? Because? The? Thopaz? Device? Showed? Unstable? Air? Leaks.?? Initially,? Soon? After? The? Thopaz? Device? Was? Powered? On,? The? Air? Leak? Was? At? 150? Ml.?? After? The? Patient's? Body,? While? In? A? Laying? Position,? Was? Moved? A? Little,? The? Air? Leak? Rose? To? 1000? Ml? And? There? Were? Some? Fluids.? The? Patient? Was? On? A? Ventilator? During? The? Surgery? And? The? 1000? Ml? Of? Air? Leak? Remained? For? 5-6? Minutes.? Afterwards,? The? Air? Leak? Remained? At? 350? Ml? For? 20-30? Minutes.?? At? That? Point,? The? Chest? Was? Re-opened,? However,? No? Air? Leak? Was? Confirmed? And? The? Device? Was? Exchanged? With? Another? Thopaz? Device? And? Its? Accessories? And? The? Patient? S? Air? Leak? Was? Without? Issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419937-2018-00054 |
| MDR Report Key | 7292935 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-02-23 |
| Date of Report | 2018-02-23 |
| Date of Event | 2017-12-22 |
| Date Facility Aware | 2017-12-22 |
| Date Mfgr Received | 2018-01-25 |
| Date Added to Maude | 2018-02-23 |
| 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 Street | 1101 CORPORATE DRIVE |
| Manufacturer City | MCHENRY IL 60050 |
| Manufacturer Country | US |
| Manufacturer Postal | 60050 |
| Manufacturer G1 | MEDELA AG |
| Manufacturer Street | LATTICHSTRASSE 4B |
| Manufacturer City | BAAR KANTON ZUG 6341 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PUMP THOPAZ |
| Generic Name | PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) |
| Product Code | BTA |
| Date Received | 2018-02-23 |
| Returned To Mfg | 2018-01-31 |
| Model Number | 0790000 |
| Catalog Number | 0790000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDELA AG |
| Manufacturer Address | LATTICHSTRASSE 4B BAAR SWITZERLAND 6341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-23 |