MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-05-31 for CARDIOHELP SYSTEM 701048012 CARDIOHELP-I 701048012 manufactured by Maquet Gmbh.
[146948637]
(b)(4). A follow-up medwatch will be submitted when additional information becomes available. (b)(4). According to the service order (b)(4) with work done on 2019-05-03 and 2019-05-06: the connection cable for disposable /hls cable was replaced, what solved the problem. After the repair the device was tested. The result was the device is ready for patient use. A similar accident was already investigated under the complaint trackwise (b)(4) with the result of the investigation report (b)(4): "the surface of the cable-socket was covered with pale residues and oxides, presumably caused by saline fluid (priming fluid). Corrective step during priming procedure would be either a covered socket, keeping it connected with hls or store it at the holder for hls connection cable on sensor panel". This complaint is being monitored as part of the complaint data trending of maquet cardiopulmonary gmbh and further investigations and measures will be conducted in case of adverse trending. Since the reported failure did not contribute to a death or serious injury no corrective action is needed. In addition at this time it cannot be concluded that it is a systemic error. No corrective action is needed.
Patient Sequence No: 1, Text Type: N, H10
[146948638]
Problem occurred during demo testing. Unit not reading arterial pressure; disposable connection/hls cable had visible saline damage on female end of connector. Complaint number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2019-00154 |
| MDR Report Key | 8659748 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-31 |
| Date of Event | 2019-05-06 |
| Date Mfgr Received | 2019-05-06 |
| Device Manufacturer Date | 2011-04-29 |
| Date Added to Maude | 2019-05-31 |
| 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 Street | MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76437 |
| Manufacturer Phone | 4972229321 |
| Manufacturer G1 | NURSEL BOELENS |
| Manufacturer Street | MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 76437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOHELP SYSTEM |
| Generic Name | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS |
| Product Code | DTQ |
| Date Received | 2019-05-31 |
| Model Number | 701048012 CARDIOHELP-I |
| Catalog Number | 701048012 |
| Lot Number | N/A |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET GMBH |
| Manufacturer Address | KEHLER STRASSE 31 RASTATT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-31 |