MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2015-07-28 for VENOUS HARDSHELL CARDIOTOMY RESERVOIR BO-HC2821 70104.7752 manufactured by Maquet Cardiopulmonary Ag.
[6634831]
On (b)(6) 2014 at the (b)(6) hospital in (b)(6) it was reported that the color of the gas indicator seal on the sterilized package of the (b)(4) cardiotomy reservoir from lot number 92128007 was brown and green which the user noticed as not typical. The cardiotomy reservoir was used for cardiac surgery along with other devices on (b)(6) 2014 and then used again for surgery on (b)(6) 2014. The patient developed an aspergillus infection of the ascending aorta after the surgery and subsequently expired. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13964137]
Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device (b)(4). The sample was discarded by the user and hence no laboratory evaluation could be performed. A review of the production records for the specific product lot was performed and no abnormalities were found. The certificate of eto (ethylene oxide) sterilization issued by the sterilization contractor was reviewed and all parameters were found to be in compliance with the specifications. The eo gas label is a qualitative indicator whose color change only indicates that the product has been exposed to eo gas. It is not a sterility claim for the product and it is not used for the release of the sterilized product. The sterile product is released on the basis of the certificate of processing from the sterilization contractor, in accordance to the validated sterilization process. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2015-00476 |
| MDR Report Key | 4945015 |
| Report Source | 01,06 |
| Date Received | 2015-07-28 |
| Date of Report | 2014-11-06 |
| Date of Event | 2014-07-14 |
| Date Facility Aware | 2014-11-06 |
| Report Date | 2014-11-06 |
| Date Reported to Mfgr | 2014-11-06 |
| Date Mfgr Received | 2014-11-06 |
| Device Manufacturer Date | 2014-03-12 |
| Date Added to Maude | 2015-07-28 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TINA EVANCHO |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097265 |
| Manufacturer G1 | MAQUET CARDIOPULMONARY AG |
| Manufacturer Street | KEHLER STRASSE 31 |
| Manufacturer City | RASTATT, 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 76437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENOUS HARDSHELL CARDIOTOMY RESERVOIR |
| Generic Name | RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS |
| Product Code | DTN |
| Date Received | 2015-07-28 |
| Model Number | BO-HC2821 |
| Catalog Number | 70104.7752 |
| Lot Number | 92128007 |
| Device Expiration Date | 2016-03-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY AG |
| Manufacturer Address | KEHLER STRASSE 31 RASTATT, 76437 GM 76437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2015-07-28 |