FDA Adverse Event
Other
Summary report: N
CURLIN 4000CMS AMBULATORY INFUSION PUMP
MDR report key: 1471377
·
Received September 10, 2009
Report
- Report Number
- 1722139-2009-00030
- Event Type
- Other
- Date Received
- September 10, 2009
- Date of Event
- August 12, 2009
- Report Date
- September 9, 2009
- Manufacturer
- CURLIN MEDICAL
- Product Code
- FRN
- Removal / Correction Number
- 2031921-2008-001-C
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO MOOG MEDICAL DEVICES GROUP AND WAS RECEIVED ON 08/13/2009 AND CONSEQUENTLY EVALUATED. A VISUAL EXAMINATION AND A VOLUMETRIC ACCURACY TEST CONFIRMED THAT THE PLATEN/DOOR LATCH WAS BENT/DAMAGED, WHICH RESULTS FROM BEING DROPPED. RESULTS: THE PUMP BEING DROPPED DIRECTLY CAUSED THE PLATEN/DOOR LATCH TO BEND, THIS CAUSING THE OVERINFUSION. CONCLUSIONS: THE BENT PLATEN LIKELY CONTRIBUTED DIRECTLY TO THE EVENT. REFERENCE FIELD CORRECTION TRACKING NUMBER: 2031921-2008-001-C.
Description of Event or Problem · 1
PUMP OVER INFUSED PHENTANYL CITRATE (B) (6). ANESTHESIOLOGIST NOTICED THAT THE BAG WAS EMPTYING FASTER THAN IT SHOULD. DETAILS PROVIDED BY STAFF RN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURLIN 4000CMS AMBULATORY INFUSION PUMP | FRN | CURLIN MEDICAL | 350-1100 | NONE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |