FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE ADMINISTRATION SET
MDR report key: 4161017
·
Received July 23, 2014
Report
- Report Number
- 9616066-2014-00685
- Event Type
- Malfunction
- Date Received
- July 23, 2014
- Date of Event
- June 23, 2014
- Report Date
- June 30, 2014
- Manufacturer
- CAREFUSION CORP.
- Product Code
- FPA
- PMA / PMN Number
- K944320
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS DISCARDED AND NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.
Description of Event or Problem · 1
CUSTOMER REPORTED A FRESH OPEN HEART PT CAME OUT OF SURGERY TO PACU WITH MULTIPLE DRIPS (DIPRIVAN AND BLOOD TRANSFUSION) INFUSING THROUGH SWAN GANZ/CORDIS CATHETERS. THE NURSES NOTICED BLOOD DRIPPING ON THE FLOOR AND AFTER FURTHER EXAMINATION THEY NOTICED THE TUBING WAS SEPARATED FROM THE SMARTSITE (DISTAL SIDE) RESULTING IN BACKFLOW OF BLOOD FROM CORDIS TUBING. NO PT HARM OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER PT/EVENT INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 430728 | ALARIS PUMP MODULE ADMINISTRATION SET | IV INFUSION SET | FPA | CAREFUSION CORP. | 2420-0007 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ALARIS PC UNIT AND PUMP MODULE, SNS # UNK| SWAN GANZ AND CORDIS CATHETERS, MODELS/LOTS # UNK |