FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE
MDR report key: 2233141
·
Received July 20, 2011
Report
- Report Number
- 2016493-2011-00430
- Event Type
- Malfunction
- Date Received
- July 20, 2011
- Report Date
- June 29, 2011
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K012383
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE HOSPITAL DISCOVERED THAT THE OVER INFUSION WAS DUE TO THE UPPER HINGE ON THE PLATEN BEING CRACKED AND ALLOWING UNREGULATED FLOW. THEY ARE PLANNING TO REPAIR THE DEVICE THEMSELVES AND WILL NOT BE RETURNING THE DEVICE FOR INVESTIGATION.
Description of Event or Problem · 1
CUSTOMER REPORTED A FLUID BOLUS TO A RENAL PT WITH CONGESTIVE HEART FAILURE IN THE PACU. THERE WAS NO PT HARM OR MEDICAL INTERVENTION. CUSTOMER STATES THAT NO FURTHER PT/EVENT INFO IS AVAILABLE. THE HOSPITAL DISCOVERED THAT OVER INFUSION WAS DUE TO THE UPPER HINGE ON THE PLATEN BEING CRACKED AND ALLOWING UNREGULATED FLOW. CUSTOMER STATED THAT PRODUCT WILL NOT BE RETURNED THEY KNOW THE CAUSE OF THE EVENT AND ARE PLANNING TO REPAIR THE DEVICE THEMSELVES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS PUMP MODULE | FRN | CAREFUSION CORPORATION | 8100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ALARIS PC UNIT, S/N UNKNOWN |