FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 3459607
·
Received November 8, 2013
Report
- Report Number
- 1416980-2013-31069
- Event Type
- Malfunction
- Date Received
- November 8, 2013
- Report Date
- October 17, 2013
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- BRZ
- PMA / PMN Number
- K993120
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
COMPLAINT NO: CMPLNT-(B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A CLEARLINK BLOOD SET Y-TYPE LARGE 170-260 MICRON FILTER HAND PUMP LEAKED FROM A HOLE LOCATED BELOW THE FILTER. THIS OCCURRED DURING INFUSION OF AN UNKNOWN DRUG. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 580200 | ACCESS | SET, BLOOD TRANSFUSION | BRZ | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |