FDA Adverse Event
Malfunction
Summary report: N
MPS DELIVERY SET W/ARREST AGENT, ADDITIVE CASS
MDR report key: 2193599
·
Received July 14, 2011
Report
- Report Number
- 1649914-2011-00008
- Event Type
- Malfunction
- Date Received
- July 14, 2011
- Date of Event
- June 15, 2011
- Report Date
- June 16, 2011
- Manufacturer
- QUEST MEDICAL
- Product Code
- DTR
- PMA / PMN Number
- 953838
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PERFUSIONIST OBSERVED FLUID HAD LEAKED FROM THE ARREST CASSETTE OF THE DELIVERY SET AND AS A RESULT HE WAS UNABLE TO SUCCESSFULLY ARREST THE PT'S HEART DURING THE PROCEDURE. THE PERFUSIONIST STATED HE THOUGHT THE FLUID APPEARED TO HAVE LEAKED DOWN INTO THE MAIN CONSOLE UNIT. AS A PRECAUTION, THE CONSOLE WAS NOT USED TO COMPLETE THE PROCEDURE. A MANUAL METHOD USING A ROLLER PUMP WAS USED INSTEAD AND THE PROCEDURE WAS COMPLETED WITH NO PT COMPLICATIONS REPORTED. THE DELIVERY SET WAS NOT RETURNED TO THE MFR FOR ANALYSIS. NO FURTHER INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MPS DELIVERY SET W/ARREST AGENT, ADDITIVE CASS | CPBP HEAT EXCHANGER | DTR | QUEST MEDICAL | 5001102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |