MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-25 for VENOUS HARDSHELL CARDIOTOMY RESERVOIR VHK 31000 701054166 manufactured by Maquet Cardiopulmonary Ag.
[81244157]
(b)(4). The product was requested but not yet received. The investigation is pending. A supplemental medwatch will be submitted when further information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[81244158]
"the customer found the blood leakage from the middle of the blue sampling line. The customer kept using the same device and finished the procedure. No adverse effect to the patient. Incident occurred during patient use. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2017-00245 |
| MDR Report Key | 6741191 |
| Date Received | 2017-07-25 |
| Date of Report | 2017-09-21 |
| Date of Event | 2017-07-13 |
| Date Mfgr Received | 2017-09-20 |
| Device Manufacturer Date | 2016-06-01 |
| Date Added to Maude | 2017-07-25 |
| 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 Street | MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 |
| Manufacturer City | 76437 RASTATT |
| Manufacturer Country | GM |
| Manufacturer Phone | 4972229321 |
| Manufacturer G1 | BERND RAKOW |
| Manufacturer Street | MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 |
| Manufacturer City | 76437 RASTATT |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VENOUS HARDSHELL CARDIOTOMY RESERVOIR |
| Generic Name | FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE |
| Product Code | DTM |
| Date Received | 2017-07-25 |
| Returned To Mfg | 2017-08-18 |
| Model Number | VHK 31000 |
| Catalog Number | 701054166 |
| Lot Number | 92206675 |
| Device Expiration Date | 2018-06-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY AG |
| Manufacturer Address | RASTATT GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-25 |