FDA Adverse Event
Malfunction
Summary report: N
ACCLAIM ENCORE 2.25
MDR report key: 1950270
·
Received December 13, 2010
Report
- Report Number
- 2921482-2010-00993
- Event Type
- Malfunction
- Date Received
- December 13, 2010
- Date of Event
- November 1, 2010
- Report Date
- November 30, 2010
- Manufacturer
- HOSPIRA, INC.
- Product Code
- FRN
- PMA / PMN Number
- K011096
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED THE PUMP DID NOT DELIVER. THE PUMP WAS RETURNED TO THE IV DEPARTMENT FOR AN UNSPECIFIED REASON. NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING AT THE USER FACILITY, THE PUMP DID NOT DELIVER WHEN THE START BUTTON WAS PRESSED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE PUMP WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCLAIM ENCORE 2.25 | 80FRN | FRN | HOSPIRA, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |