MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-08 for RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS VKMO10000 70105019 manufactured by Maquet Cardiopulmonary Ag.
[67228870]
(b)(4). A follow-up medwatch will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[67228871]
According to the customer: "this device was used on a neonatal patient, for a tetrology of fallot procedure. Pre-procedurally the patient had act of 600, during bypass 580 anf then at end of procedure 400+. Platelets were normal, no heparin given. Tubing set was blood-primed with no products added. During the case the volume dropped from 250ml by 50ml (which is normal) at which point the perfusion noticed a clot forming within the screen of the reservoir. The clot was of pasty consistency. There was no clot found on the arterial outlet or within the arterial filter. The hospital are not sure what caused the clot, but felt it necessary to report, nonetheless. Unfortunately the device was discarded at the end of the procedure. The procedure was completed normally, there was no effect to the patient, who was discharged normally from icu. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[130077755]
(b)(4). The visual investigation of the received pictures showed that the reservoir shows clotting. The sample was discarded by the hospital. Clotting is a known phenomenon to maquet and has been thoroughly investigated in a previous complaints,4 additional complaints were recorded. Device history record of the lot has been investigated and no abnormality was found. An internal clinical assessment was performed based on the received complaint report. Though the device of complaint was coated clotting may occur when the perfusion takes a steady course over a longer period of time. When the preload and afterload conditions solely changes slightly and the suction/vent volume also maintaining steady. The initial act level was high but the report mentions that no additional heparin given. It is unknown what exactly 400+act mean and as a combination of a steady perfusion with a slightly low anticoagulation a promotion of coagulation could have occurred. The high activated suction blood probably increased the progression of the clotting. Furthermore the report states the volume dropped during the case and so the viscosity of the perfusate may have increased and also contributed to the clotting. It is not reported and remains unclear if not coagulatory substances,such as blood substitution products have been applied during the case,which likely could have promoted the finding. The photographs unveil significant filter thrombosis,but a conclusive assessment is barely possible. Even with more information from the hospital it is hard to determine. Taking the accessible information into consideration it is deemed to be not necessarily hence a sole device mal-performance. The exact root cause of the failure could not be determined. This data will be handled through a designated maquet trending process.
Patient Sequence No: 1, Text Type: N, H10
[130077756]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2017-00037 |
| MDR Report Key | 6311659 |
| Date Received | 2017-02-08 |
| Date of Report | 2017-07-11 |
| Date of Event | 2017-01-10 |
| Date Mfgr Received | 2017-01-11 |
| Device Manufacturer Date | 2016-02-01 |
| Date Added to Maude | 2017-02-08 |
| 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 | RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS |
| Generic Name | FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE |
| Product Code | DTM |
| Date Received | 2017-02-08 |
| Model Number | VKMO10000 |
| Catalog Number | 70105019 |
| Lot Number | 92187533 |
| Device Expiration Date | 2018-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-02-08 |