FDA Adverse Event
Malfunction
Summary report: N
INFUSOR
MDR report key: 3972457
·
Received August 1, 2014
Report
- Report Number
- 1416980-2014-24949
- Event Type
- Malfunction
- Date Received
- August 1, 2014
- Report Date
- July 7, 2014
- Manufacturer
- BAXTER HEALTHCARE - IRVINE
- Product Code
- MEB
- PMA / PMN Number
- K071222
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INFUSION STARTED ON AN UNSPECIFIED DATE AND ENDED ON (B)(6) 2014. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED A SMALL VOLUME INFUSOR (2ML/HOUR) EXPERIENCED AN OVERINFUSION. THE REPORTER STATED THAT THE INFUSION COMPLETED 18 HOURS EARLIER THAN EXPECTED. THIS OCCURRED DURING INFUSION OF AN UNKNOWN DRUG. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 450059 | INFUSOR | PUMP, INFUSION, ELASTOMERIC | MEB | BAXTER HEALTHCARE - IRVINE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |