MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2014-10-22 for CARDIOHELP SYSTEM BE-PLS 2051 70105.0310 manufactured by Maquet Cardiopulmonary Ag.
[17581245]
It was reported the device was on an ecmo (extra corporeal membrane oxygenation) patient for a period of five days. During this time, a pink solution (as if condensation) was observed coming out from the bottom of the device. Pressure parameters were normal throughout treatment. The device was not swapped out. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[17808376]
Maquet cardiopulmonary is aware of similar complaints. The devices displayed a similar malfunction which were tested and evaluated under an optical microscope. Delamination of some gas fibers was observed which allowed for the priming solution or blood to flow inside the gap between the gas fibers and polyurethane. Gravity then allowed for passage to the gas exiting path along the housing. The most probable root-cause is the delamination of the hollow gas fibers from the polyurethane potting area. A review of the quality control process confirms that 100% functional inspection for leakage is performed during production. Maquet cardiopulmonary (b)(4) has initiated an internal process ((b)(4)) to address the appropriate corrective and preventive action. A supplemental medwatch will be submitted when new information becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2014-00817 |
| MDR Report Key | 4208745 |
| Report Source | 01,06 |
| Date Received | 2014-10-22 |
| Date of Report | 2014-09-23 |
| Date of Event | 2014-09-22 |
| Date Mfgr Received | 2014-09-23 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2014-11-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL CAMPBELL |
| Manufacturer Street | KEHLER STRASSE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76437 |
| Manufacturer Phone | 2229321132 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOHELP SYSTEM |
| Generic Name | TUBING SET |
| Product Code | MWJ |
| Date Received | 2014-10-22 |
| Returned To Mfg | 2014-10-14 |
| Model Number | BE-PLS 2051 |
| Catalog Number | 70105.0310 |
| Lot Number | 70097053 |
| Device Expiration Date | 2016-04-01 |
| 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 | 2014-10-22 |