MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-02-07 for THOPAZ+ PUMP SALE 079100 manufactured by Medela Ag.
[99188450]
The? Device? Was? Returned? To? Medela? (b)(4) for? Evaluation,? Which? Was? Conducted? By? A? Certified? Technician? On? (b)(6) 2017.?? All? Of? The? Data? From? The? Device? Was? Downloaded? And? Analyzed? And? It? Indicated? That? The? Device? Was? Working? As? Intended.?? It? Was? Also? Determined? That? There? Appeared? To? Have? Been? No? Harm? To? The? Device? As? A? Result? Of? The? Impact? From? The? Patient? Dropping? It? On? The? Floor.?? During? Testing,? The? Device? Correctly? Showed? A? Flow? Of? 0? Ml/min,? Which? Indicated? That? The? Device? Was? Working? As? Intended. It? Was? Determined? That? The? Tru-close? System? Should? Not? Be? Used? With? The? Thopaz+? Device.?? The? Tru-close? System? Was? Clogged? With? Coagulated? Blood? And,? Therefore,? The? Thopaz+? Device? Only? Showed? The? Flow? From? The? Clogged? Chest? Tube? To? The? Device. In? The? Instructions? For? Use,? Page? 7,? It? Is? Written? That? "medela? Can? Only? Guarantee? The? Safe? Functioning? Of? The? System? When? The? Thopaz+? Is? Used? In? Combination? With? The? Original? Thopaz+? Accessories? (canisters,? Tubings,? Carrying? Strap,? Mains? Adapter,? And? Docking? Station). "?? To? Work? Optimally? As? Intended,? The? Thopaz+? System? Must? Be? Connected? Directly? To? The? Pleural? Space? Through? A? Normal? Chest? Tube.?? The? Device? Does? Not? Work? Optimally? And? As? Intended? With? Another? Chest? Tube? System,? Especially? If? That? System? Is? Clogged.?? The? Clinical? Staff,? Doctors? And? Nurses? At? The? (b)(6) hospital? Were? Trained? That? The? Two? Systems? Should? Only? Be? Used? Separately.
Patient Sequence No: 1, Text Type: N, H10
[99188531]
On (b)(6) 2017:? The? Patient? Was? Diagnosed? At? (b)(6) hospital? With? A? Pneumothorax,? And? A? Chest? Tube? Called? Tru-close? Was? Placed.? On (b)(6) 2017:? The? Tru-close? System? Was? Connected? To? A? Thopaz+? Device? Because? The? Lung? Was? Not? Expanding.?? The? Negative? Pressure? Was? Set? At? -10? Cm? H2o.?? Initially,? An? Air? Leak? Of? 700? Ml/min? Was? Detected,? But? Shortly? After,? The? Air? Leak? Was? At? 0? Ml/min.? Subsequently,?? Shortly? After? The? Chest? Tube? Insertion,? The? Patient? Informed? Hospital? Staff? That? He? Dropped? The? Thopaz+? Device? On? The? Floor.? The? Pump? Appeared? To? Work? Afterwards.?? At? That? Time,? The? Staff? Did? Not? Check? The? Catheter? To? Determine? If? The? Patient? Catheter? Was? Open? Or? Clogged. On (b)(6) 2017:?? After? One? Day,? A? New? X-ray? Of? The? Thorax/lung? Was? Taken,? Which? Showed? An? Increasing? Pneumothorax.? The? Patient? Was? Not? Worsening? Clinically? Nor? From? A? Respiratory? Standpoint.? In? The? Patient's? Medical? Record,? It? Was? Described? That? There? Was? Visible? Coagulated? Blood? In? The? Tube.?? As? A? Result,? The? Staff? Flushed? The? Tru-close? Tube? With? Saline? To? Remove? The? Coagulated? Blood? From? The? Tru-close? System? And? They? Changed? The? Thopaz+? Device? To? A? Traditional? Water? Seal? Drainage? System.?? An? X-ray? Of? The? Lung? After? 2? Hours? With? The? Traditional? System? Showed? Improvement? Of? The? Pneumothorax,? As? The? System? Was? No? Longer? Clogged. On (b)(6) 2017:?? The? Patient? Was? Transferred? To? (b)(6)? Hospital? To? The? Cardio-thoracic? Department? Because? Of? Increasing? Pneumothorax. On (b)(6) 2017:?? The? Patient? Was? Transferred? Back? At? (b)(6) hospital? Without? Any? Chest? Tube? Or? Drainage? System? And? Was? Sent? Home? Shortly? Thereafter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419937-2018-00033 |
| MDR Report Key | 7247003 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-02-07 |
| Date of Report | 2018-02-07 |
| Date of Event | 2017-07-27 |
| Date Facility Aware | 2018-02-05 |
| Date Mfgr Received | 2017-08-28 |
| Device Manufacturer Date | 2016-08-26 |
| Date Added to Maude | 2018-02-07 |
| 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 | ROBERT SOKOLOWSKI |
| 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 | THOPAZ+ PUMP SALE |
| Generic Name | PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) |
| Product Code | BTA |
| Date Received | 2018-02-07 |
| Model Number | 079100 |
| Catalog Number | 079100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDELA AG |
| Manufacturer Address | LATTICHSTRASSE 4B BAAR KANTON ZUG 6341 SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-07 |