MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2013-10-08 for MAQUET CARDIOPULMONARY AG 70102.8580 manufactured by Maquet Cardiopulmonary Ag.
[20107073]
It was reported that the customer felt they had over occluded the roller on a twin roller pump which caused the pump tubing to rupture. This event occurred post support/bypass so there was no patient effect. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[20484179]
Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4). Maquet cardiopulmonary (b)(4) provides product failure investigation, analysis and resolution for the device described in this report. The ifu for the hl20 describes how to change the occlusion of the pump. It is noted in the ifu that an incorrectly adjusted occlusion can influence the life time of a tube.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2013-00051 |
| MDR Report Key | 3459119 |
| Report Source | 05,06,07 |
| Date Received | 2013-10-08 |
| Date of Report | 2013-09-11 |
| Date of Event | 2013-09-11 |
| Date Facility Aware | 2013-09-11 |
| Report Date | 2013-10-08 |
| Date Reported to Mfgr | 2013-09-12 |
| Date Mfgr Received | 2013-09-12 |
| Date Added to Maude | 2014-01-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JANICE PEVIDE |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097753 |
| Manufacturer G1 | MAQUET CARDIOPULMONARY AG |
| Manufacturer Street | 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 | MAQUET CARDIOPULMONARY AG |
| Generic Name | HL 20 4-PUMPS CONSOLE BASE |
| Product Code | DPW |
| Date Received | 2013-10-08 |
| Model Number | 70102.8580 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY AG |
| Manufacturer Address | RASTATT GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-08 |