FDA Adverse Event
Malfunction
Summary report: N
CADD EXTENSION SET SET
MDR report key: 13523466
·
Received February 14, 2022
Report
- Report Number
- 3012307300-2022-03313
- Event Type
- Malfunction
- Date Received
- February 14, 2022
- Report Date
- February 14, 2022
- Manufacturer
- ST PAUL
- Product Code
- FPA
- UDI-DI
- 10610586023279
- PMA / PMN Number
- K000942
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
REPORT SOURCE:(B)(6). ADDITIONAL CONTACT INFORMATION: TOLL-FREE SUPPORT LINE: 1-866-206-4441, [email protected].
Description of Event or Problem · 0
INFORMATION WAS RECEIVED INDICATING THAT A PUMP USING A CADD EXTENSION SET WAS LEAKING AT THE FILTER AND HAD AN AIR BUBBLE IN THE TUBING. IT WAS REPORTED A SECOND INCIDENT OCCURRED DURING THE SAME WEEK AND THE LEAKAGE OCCURRED ABOUT 12 TO 16 HOURS AFTER THE TUBING WAS IN USE AND HAD BEEN PROPERLY PRIMED WITH NO AIR BUBBLES. PER REPORTER THE END USER WAS ABLE TO CHANGE OUT THE EXTENSION TUBING WITH A DIFFERENT LOT AND CASSETTE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1082146 | CADD EXTENSION SET SET | ADMINISTRATION, INTRAVASCULAR | FPA | ST PAUL | 21-7106-24 | 4046838 | 10610586023279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |