MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-16 for CENTRIMAG BLOOD PUMP 102953 manufactured by Thoratec Switzerland Gmbh.
[183609940]
The outflow graft infection was reported under mfr 2916596-2020-01306. No further information was provided. A supplemental report will be submitted when the manufacturer? S investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[183609941]
It was reported that the patient developed a large abscess in his mediastinum around his outflow graft that had traveled through the abdominal muscle to the substernal tissue. The patient originally presented with a fever and had (b)(6) cultured on (b)(6) 2020. The culture was staph aureus. The patient developed chest pain on (b)(6) 2020 and a ct (computerized tomography) scan was performed and found a fluid collection around the outflow graft. Despite antibiotics the patient continued to be febrile and his status declined. On (b)(6) 2020 the patient's infection had tunneled through the abdominal muscle and was a visible pulsatile abscess below his sternum. The patient was taken to the operating room on (b)(6) 2020 to drain the abscess. An echo and ultra sound was performed. The hm3 (heartmate 3) was removed and the patient was placed on ecmo (extracorporeal membrane oxygenation). The patient was upgraded on unos list status for an urgent heart transplant. The hm3 outflow graft was successfully removed and ecmo was initiated. It was suspected that the patient went into dic (disseminated intravascular coagulation) from sepsis as the patient quickly clotted off both the ecmo circuit and the cardiopulmonary bypass circuit despite it being reported that the patient was adequately anticoagulated. The patient had no pressure at this time and nothing further could be done. Time of death was pronounced and the patient died on (b)(6) 2020. The death was not considered to be device related. The patient had no history of infections or operations post implant. It was unclear how the patient developed the abscess. The source could no be identified. The death was reported to be due to dic (disseminated intravascular coagulation).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-01463 |
| MDR Report Key | 9836940 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-03-16 |
| 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 | MR. BOB FRYC |
| Manufacturer Street | TECHNOPARKSTRASSE 1 |
| Manufacturer City | ZURICH CH-8005 |
| Manufacturer Country | SZ |
| Manufacturer Postal | CH-8005 |
| Manufacturer Phone | 78185 |
| Manufacturer G1 | THORATEC SWITZERLAND GMBH |
| Manufacturer Street | TECHNOPARKSTRASSE 1 |
| Manufacturer City | ZURICH CH-8005 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-8005 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTRIMAG BLOOD PUMP |
| Generic Name | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE |
| Product Code | KFM |
| Date Received | 2020-03-16 |
| Model Number | 102953 |
| Lot Number | L05811-LA6 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC SWITZERLAND GMBH |
| Manufacturer Address | TECHNOPARKSTRASSE 1 ZURICH CH-8005 SZ CH-8005 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-16 |