MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06,07,08,company rep report with the FDA on 2015-04-30 for HC 2821-J#KARDIOTOMIERESERVOIR 70103.1718 manufactured by Maquet Cardiopulmonary Ag.
[16467295]
It was reported that: "when the user tried to connect the extracorporeal blood circuit of heart-lung machine to the reservoir, the two sucker connectors (blue ports) of the reservoir were broken. So the user re-connected the blood circuit to the unfiltered connectors (on the top of the main body) of the reservoir. The surgery operation was not affected by this incident". (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[16766644]
A f/u medwatch will be send after receiving further info.
Patient Sequence No: 1, Text Type: N, H10
[75461942]
Sample has been discarded by the hospital, therefore no investigation on the sample is possible. Visual inspection has been performed on the pictures sent along with the complaint. Thus failure could be confirmed. Dhr-review of 70103. 1718, lot: 70095057 shows no abnormalities. This data will be handled through a designated maquet trending process. If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary. Due to this no further action will be completed at this time.
Patient Sequence No: 1, Text Type: N, H10
[75461943]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2015-00421 |
| MDR Report Key | 4745311 |
| Report Source | 00,01,05,06,07,08,COMPANY REP |
| Date Received | 2015-04-30 |
| Date of Report | 2015-04-13 |
| Date of Event | 2015-04-13 |
| Date Mfgr Received | 2015-10-06 |
| Device Manufacturer Date | 2013-09-01 |
| Date Added to Maude | 2015-06-08 |
| 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 Contact | MICHAEL CAMPBELL |
| Manufacturer Street | KEHLER STRASSE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76437 |
| Manufacturer Phone | 2229321132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HC 2821-J#KARDIOTOMIERESERVOIR |
| Product Code | DTN |
| Date Received | 2015-04-30 |
| Model Number | 70103.1718 |
| Catalog Number | HC 2821-J |
| Lot Number | 70095057 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2015-04-30 |