FDA Adverse Event
Injury
Summary report: N
MPS DELIVERY SET W AA AND ADD CASSETTES
MDR report key: 2563359
·
Received May 3, 2012
Report
- Report Number
- 1649914-2012-00006
- Event Type
- Injury
- Date Received
- May 3, 2012
- Date of Event
- April 1, 2012
- Report Date
- April 5, 2012
- Manufacturer
- QUEST MEDICAL, INC.
- Product Code
- DTR
- PMA / PMN Number
- K953838
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). QUEST MEDICAL, INC. HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
THE PERFUSIONIST REPORTED THAT DURING THE PROCEDURE WHILE THE CIRCULATION PUMP WAS ON, HE OBSERVED AIR BUBBLES MOVING ACROSS THE SEALED AREA ON THE DISPOSABLE CASSETTE. THIS COULD POSE A POTENTIAL WATER-TO-BLOOD LEAK SCENARIO. AS A PRECAUTION THE PT WAS GIVEN ADDITIONAL ANTIBIOTICS AND WATCHED FOR ANY INFECTION. THE DISPOSABLE CASSETTE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THERE HAVE BEEN NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS ALLEGED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MPS DELIVERY SET W AA AND ADD CASSETTES | CPBP HEAT EXCHANGER | DTR | QUEST MEDICAL, INC. | 5001102 | 0408731C10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |