FDA Adverse Event
Death
Summary report: N
AMBIT PCA MILITARY PUMP/CASSETTE FILTER MALE
MDR report key: 2308987
·
Received October 21, 2011
Report
- Report Number
- 1722214-2011-00006
- Event Type
- Death
- Date Received
- October 21, 2011
- Date of Event
- August 25, 2010
- Report Date
- October 20, 2011
- Manufacturer
- SUMMIT MEDICAL PRODUCTS, INC.
- Product Code
- MEA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AMBIT PUMP/CASSETTE PERFORMED WITHIN SPECIFICATION.
Description of Event or Problem · 1
ON 09/22/2011, (B)(4) FROM BAXTER CONTACTED SUMMIT MEDICAL PRODUCTS, INC. SHE INFORMED US THAT (B)(6) CONTACTED HER IN APRIL 2011 REGARDING A DEATH OF A (B)(6) PATIENT. WHEN THE PRODUCT WAS RETURNED TO BAXTER THEY ALSO HAD ONE OUR PUMPS THAT WAS ON THE PATIENT AT THE TIME OF DEATH. HOWEVER SUMMIT MEDICAL WAS NEVER CONTACTED UNTIL 09/22/2011. WE REQUESTED THE PRODUCT BE RETURNED TO US. (B)(4) (BAXTER) STATED THAT THE PRODUCT WOULD FIRST NEED TO GO BACK TO (B)(6). (B)(6) CONTACTED SUMMIT MEDICAL AND STATED THAT HE NEEDED US TO VERIFY THAT THE PRODUCT FUNCTIONED CORRECTLY. HE STATED THAT WHEN HE RETURNED THE PUMP(S) TO BAXTER IN (B)(6) 2011, HE ASSUMED THAT THEY BOTH BELONGED TO BAXTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMBIT PCA MILITARY PUMP/CASSETTE FILTER MALE | AMBIT PCA MILITARY PUMP/CASSETTE FILTER | MEA | SUMMIT MEDICAL PRODUCTS, INC. | 220437/220266 | 910017/UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |