MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,study,user faci report with the FDA on 2015-08-03 for HEART-LUNG MACHINE HL20 70102.8580 manufactured by Maquet Cardiopulmonary Ag.
[22439194]
A field safety technician opened the rpm and one belt is broken (the second one seems to be ok). He measured the belt tension 445 hz. Possible root cause: defective belt from a factory, tension too high, maybe combination of both. He repaired (belt replacement) / ordering new motor isolation kit for better adjustment of tension. The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process. Due to this no further investigation initiations will be completed at this time.
Patient Sequence No: 1, Text Type: N, H10
[22439195]
It was reported that during the surgery, the rpm module reported an error "belt slip". The perfusionist stopped the pump but the error was still there. So they stopped the "suction" function. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2015-00866 |
| MDR Report Key | 4972743 |
| Report Source | FOREIGN,OTHER,STUDY,USER FACI |
| Date Received | 2015-08-03 |
| Date of Report | 2015-07-24 |
| Date of Event | 2015-07-24 |
| Date Added to Maude | 2015-08-05 |
| 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 | MICHAEL CAMPBELL |
| Manufacturer Street | KEHLER STRABE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76437 |
| Manufacturer Phone | 2229321132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HEART-LUNG MACHINE HL20 |
| Product Code | DPW |
| Date Received | 2015-08-03 |
| Model Number | 70102.8580 |
| Catalog Number | 70102.8580 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY AG |
| Manufacturer Address | RASTATT GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-03 |