FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE IV ADMINISTRATION SET
MDR report key: 2251680
·
Received August 31, 2011
Report
- Report Number
- 9616066-2011-00511
- Event Type
- Malfunction
- Date Received
- August 31, 2011
- Date of Event
- July 30, 2011
- Report Date
- August 9, 2011
- Manufacturer
- CAREFUSION CORP.
- Product Code
- FPA
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ALTHOUGH REQUESTED, THE SET HAS NOT BEEN RECEIVED. A F/U REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE SET BE RECEIVED FOR EVAL.
Description of Event or Problem · 1
CUSTOMER REPORTED PT NOTIFIED NURSE HE WAS BLEEDING. THE NURSE FOUND THERE WAS BLOOD ON THE PT GOWN AND IT WAS COMING FROM THE PT'S IV TUBING. IV TUBING WAS CLAMPED AND ON FURTHER INSPECTION FOUND THE TUBING HAD COME APART. PT DOES NOT KNOW WHAT HAPPENED, HE DENIES PULLING ON THE TUBING. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION REQUIRED. ALTHOUGH REQUESTED, NO FURTHER PT OR EVENT INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS PUMP MODULE IV ADMINISTRATION SET | FPA | CAREFUSION CORP. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |