FDA Adverse Event
Injury
Summary report: N
ALARIS ADMINISTRATION SET
MDR report key: 1851639
·
Received September 29, 2010
Report
- Report Number
- 9616066-2010-00267
- Event Type
- Injury
- Date Received
- September 29, 2010
- Date of Event
- August 16, 2010
- Report Date
- September 8, 2010
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K944320
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. THE SET WAS DISCARDED AT THE FACILITY. THE MODEL AND LOT NUMBER WERE NOT IDENTIFIED.
Description of Event or Problem · 1
CUSTOMER REPORTED THE IV TUBING WAS RUN OVER BY IV POLE WHILE THE PATIENT HAD GOTTEN OUT OF BED. THE PATIENT HAD A PICC LINE AND BLOOD FROM THE PATIENT LEAKED OUT FROM A CRACK IN THE IV TUBING. PATIENT REQUIRED A BLOOD TRANSFUSION BECAUSE OF THE BLEEDING. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS ADMINISTRATION SET | FPA | CAREFUSION CORPORATION | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |