FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE IV ADMINISTRATION SET
MDR report key: 2090519
·
Received April 19, 2011
Report
- Report Number
- 9616066-2011-00131
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Report Date
- March 25, 2011
- Manufacturer
- CAREFUSION CORP.
- Product Code
- FPA
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
MFR'S REPORT DATE: APRIL 18, 2011. (B)(6). ALTHOUGH DEVICE RETURN IS EXPECTED, IT HAS NOT YET BEEN RECEIVED. A F/U REPORT WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND INVESTIGATED OR ADDITIONAL INFO IS OBTAINED.
Description of Event or Problem · 1
AN INFANT IN THE NICU WAS ON AN INFUSION OF D10W. THE NURSE IDENTIFIED A MINUTE HOLE IN THE SET WHERE THE FILTER CONNECTS TO THE TUBING. A SIGNIFICANT AMOUNT OF BLOOD BACKED UP INTO THE TUBING AND THE D10W SOLUTION WAS LEAKING INTO THE BED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS PUMP MODULE IV ADMINISTRATION SET | FPA | CAREFUSION CORP. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |