FDA Adverse Event
Malfunction
Summary report: N
COMPOUNDERS
MDR report key: 2691095
·
Received August 10, 2012
Report
- Report Number
- 6000001-2012-13126
- Event Type
- Malfunction
- Date Received
- August 10, 2012
- Date of Event
- April 26, 2012
- Report Date
- April 26, 2012
- Manufacturer
- BAXTER HEALTHCARE - LARGO
- Product Code
- NEP
- Removal / Correction Number
- 6000001-07/13/12-001-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION SUMMARY: THE REPORTED PROBLEM OF A "FRAYED UMB CABLE" WAS CONFIRMED DURING VISUAL INSPECTION. THE CAUSE WAS DETERMINED TO BE A DAMAGED UMBILICAL CABLE. THERE WERE NO REPAIRS OR UPGRADES PERFORMED ON DEVICE SINCE IT IS A STAY IN UNIT. ADDITIONAL INFORMATION: THIS DEVICE IS CLASS II EXEMPT FROM HAVING A 510(K) NUMBER. ITS ADDITIONAL 510(K) NUMBER IS K961008.
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
BAXTER RECEIVED A REPORT FROM A FACILITY INVOLVING AN AUTOMIX 3+3/AS COMPOUNDER. ACCORDING TO THE FACILITY, THE UMB (UMBILICAL) CABLE WAS FRAYED. THE UNIT IS BEING SWAPPED. THERE WAS NO PATIENT INVOLVEMENT AND THEREFORE NO MEDICAL INTERVENTION OR ADVERSE EVENT. NO FURTHER INFORMATION WAS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMPOUNDERS | SYSTEM/DEVICE, PHARMACY COMPOUNDING | NEP | BAXTER HEALTHCARE - LARGO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |