MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-06-28 for VENOUS BUBBLE TRAP (VBT) BE-VBT 160 70103.0118 manufactured by Maquet Cardiopulmonary Ag.
[48362044]
(b)(4). Maquet cardiopulmonary (b)(4) requested the product back for investigation and received it on 06/24/2016. Device history record of the complained lot has been reviewed by maquet cardiopulmonary (b)(4). Thereby no abnormality was found for the related material. All the controls were done according to the process control form, also, it was controlled that the leakage test in the vbt production was performed. A supplemental medwatch will be submitted when further information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[48362065]
Description from the customer report: "not able to suck the collected air on top of the venous bubble trap on the usual way. They finally managed to do this manually with a syringe" (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[74377758]
Maquet cardiopulmonary (b)(4) requested the product back for investigation and received it on 06/24/2016. Our customers need to fill out a declaration of infection risk. If this document is not received we are not able to investigate the product. In case # (b)(4) the hospital did not fill out the declaration of infection risk completely due to given law in the (b)(6) they are not allowed to fill out a section. Therefore, the sample could not investigated by our laboratory. On the other hand, device history record of the complained lot has been reviewed by maquet cardiopulmonary (b)(4) and no abnormality was found for the related material. All the controls were done according to the process control form, also, it was controlled that the leakage test in the vbt production was performed. A sap trend search has been performed (search for material and component number 70103. 0118, error message: 1000) which came to following result: no additional complaint were recorded. Based on this, a confirmation of the failure based on previous complaints is not possible, and there is no systemic issue indicated.
Patient Sequence No: 1, Text Type: N, H10
[74377759]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2016-00413 |
| MDR Report Key | 5755937 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-06-28 |
| Date of Report | 2017-04-26 |
| Date of Event | 2016-06-06 |
| Date Mfgr Received | 2017-04-26 |
| Device Manufacturer Date | 2015-11-01 |
| Date Added to Maude | 2016-06-28 |
| 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 | 3 |
| Brand Name | VENOUS BUBBLE TRAP (VBT) |
| Generic Name | DEFOAMER, CARDIOPULMONARY BYPASS |
| Product Code | DTP |
| Date Received | 2016-06-28 |
| Returned To Mfg | 2016-06-24 |
| Model Number | BE-VBT 160 |
| Catalog Number | 70103.0118 |
| Lot Number | 92187089 |
| Device Expiration Date | 2017-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY AG |
| Manufacturer Address | RASTATT GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-06-28 |