FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE ADMINISTRATION SET,
MDR report key: 3221994
·
Received July 3, 2013
Report
- Report Number
- 9616066-2013-00495
- Event Type
- Malfunction
- Date Received
- July 3, 2013
- Date of Event
- June 13, 2013
- Report Date
- June 14, 2013
- Manufacturer
- CAREFUSION CORP
- Product Code
- FPA
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A F/U REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE AFFECTED DEVICE BE RECEIVED FOR EVAL.
Description of Event or Problem · 1
THE CUSTOMER REPORTED "THE BLUE PART THAT RESTS AT THE TOP OF THE DOOR CAME OFF". THE SILICONE TUBING TORE OFF WHILE THE NURSE WAS TROUBLESHOOTING AN OCCLUSION. THERE WAS NO REPORT OF PT OR MEDICAL INTERVENTION. NO FURTHER PT OR EVENT INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303640 | ALARIS PUMP MODULE ADMINISTRATION SET, | FPA | CAREFUSION CORP | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ALARIS PC UNIT: SN UNK| ALARIS PUMP MODULE: SN UNK |