FDA Adverse Event
Other
Summary report: N
VENOUS BLOOD LINE PRE & POST PUMP INJ SITE & LVL ADJ
MDR report key: 144603
·
Received January 15, 1998
Report
- Report Number
- 1423500-1998-00024
- Event Type
- Other
- Date Received
- January 15, 1998
- Date of Event
- December 1, 1997
- Report Date
- December 22, 1997
- Manufacturer
- NMC
- Product Code
- FJK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
HEALTHCARE PROFESSIONAL (HCP) REPORTS A HOME HELPER CARING FOR THE HOME HEMODIALYSIS PT NOTED MICROBUBBLES IN THE VENOUS LINE BETWEEN THE DRIP CHAMBER AND THE PTS' ACCESS DURING HEMODIALYSIS TREATMENT. THE PT THE COMPLAINED OF A HEADACHE. THE HOME HELPER IMMEDIATELY STOPPED TREATMENT AND CALLED 911. THE PT WAS TRANSFERRED TO THE ER VIA AMBULANCE. THE PT WAS ADMITTED AND AN MRI PERFORMED. NO AIR EMBOLISM NOTED AND HOME PT WAS RELEASED TO HOME THE FOLLOWING DAY. HCP REPORTS SOURCE OF HEADACHE WAS UNDETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENOUS BLOOD LINE PRE & POST PUMP INJ SITE & LVL ADJ | BLOOD LINE | FJK | NMC | NA | NA01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Hospitalization | COBE C2 HEMODIALYSIS DEVICE |