MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06 report with the FDA on 2015-07-15 for BO-HQV 70600 ADULT PACK VKMO 71000 70106.3877 manufactured by Maquet Cardiopulmonary Ag.
[6025331]
According to the customer: "user observed an air leakage on the heat probe which is placed in venous line of the oxygenator. Problem was continued even though the user had done essential actions. Non-conformity was observed almost at the end of the surgery, and the questioned product was not replaced with a new one. No harm occurred in the pt. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[14028746]
Maquet cardiopulmonary ag is aware of similar complaints with similar malfunction. Due to this we take these complaints as an input to start an internal project with the intention to review aspects of the design, the mfg process and the test methods. This review should cover all possible impacts of the quality the vhk71000 reservoir. Additional info: the product mentioned is a tubing set with reservoir and the included affected component has the contributing design function of the reservoir which is registered under 510 (k): k102919.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2015-00810 |
| MDR Report Key | 4921174 |
| Report Source | 00,01,05,06 |
| Date Received | 2015-07-15 |
| Date of Report | 2015-07-01 |
| Date of Event | 2015-06-22 |
| Date Mfgr Received | 2015-07-06 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2015-07-22 |
| 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 | 29321132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BO-HQV 70600 ADULT PACK |
| Product Code | DTN |
| Date Received | 2015-07-15 |
| Model Number | VKMO 71000 |
| Catalog Number | 70106.3877 |
| Lot Number | 92131225 |
| Device Expiration Date | 2015-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2015-07-15 |