FDA Adverse Event
Malfunction
Summary report: N
PERFUSOR SPACE
MDR report key: 1931715
·
Received November 22, 2010
Report
- Report Number
- 1641965-2010-00108
- Event Type
- Malfunction
- Date Received
- November 22, 2010
- Report Date
- November 1, 2010
- Manufacturer
- B. BRAUN MEDICAL, INC
- Product Code
- FRN
- PMA / PMN Number
- K062699
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE EVAL IS CURRENTLY UNDERWAY. A F/U REPORT WILL BE SUBMITTED AFTER THE EVAL IS COMPLETED.
Description of Event or Problem · 1
REPORTED UNDER-INFUSION. PT WAS A PREEMIE NEWBORN. PUMP SET TO INFUSE 0.5CC OF LIPIDS PER HR. AT 8PM, NURSE STATED SYRINGE WAS GREATER THAN 10ML ESTIMATED SYRINGE SHOULD HAVE 10.2 ML REMAINING. REMAINING SYRINGE WAS TAKEN OUT AND REINSERTED, ALSO LABEL WAS REMOVED IN CASE THERE WAS INTERFERENCE. USED A MONOJET 20CC SYRINGE (B)(4). NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERFUSOR SPACE | INFUSION PUMP | FRN | B. BRAUN MEDICAL, INC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |