FDA Adverse Event
Malfunction
Summary report: N
COOL POINT PUMP
MDR report key: 2121762
·
Received May 20, 2011
Report
- Report Number
- 2030404-2011-00149
- Event Type
- Malfunction
- Date Received
- May 20, 2011
- Date of Event
- April 22, 2011
- Report Date
- April 22, 2011
- Manufacturer
- ST. JUDE MEDICAL, IRVINE
- Product Code
- FRN
- PMA / PMN Number
- P060019-S005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE HAS NOT BEEN REC'D FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED WHILE USING THE PUMP FOR A PROCEDURE, THERE WAS A BUBBLE ALARM ON THE PUMP. HOWEVER, WHEN THE TUBING WAS REMOVED AND REINSERTED, THE PUMP NEVER REVEALED ANY BUBBLES DESPITE THE PHYSICIAN STATING THAT HE COULD VISUALIZE THE BUBBLES IN THE TUBING BEFORE THEY ENTERED THE BUBBLE SENSOR AND THEY FLOWED THROUGH THE SENSOR WITH NO ALARM OR STOPPING OF THE PUMP. THE TUBING SETS WERE CHANGED TWICE AND THE PROBLEM CONTINUED. THERE WERE NO CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOL POINT PUMP | PUMP, INFUSION | FRN | ST. JUDE MEDICAL, IRVINE | 85784 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |