FDA Adverse Event Other Summary report: N

ON-Q C-BLOC

MDR report key: 1029613 · Received April 11, 2008

Report

Report Number: 2026095-2008-00030
Event Type: Other
Date Received: April 11, 2008
Date of Event: March 12, 2008
Report Date: March 13, 2008
Manufacturer: I-FLOW CORPORATION
Product Code: MEB
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

EVAL SUMMARY: THE SAMPLE WAS REPORTED AS AVAILABLE, BUT HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED THAT THE RED TAB KEY HAD BEEN LEFT IN THE BOLUS ASSEMBLY WHILE THE PUMP WAS IN USE. THE PUMP EMPTIED RAPIDLY. THE DIRECTORS FOR USE (DFU) CONTAIN A WARNING THAT STATES: "TO REDUCE POTENTIAL ADVERSE EFFECTS: 2. RED TAB MUST BE REMOVED BEFORE USE. IF RED TAB IS NOT REMOVED BEFORE USE OR BREAKS WHILE REMOVING, BOLUS BUTTON WILL NOT WORK AND FLOW RATE MAY INCREASE SIGNIFICANTLY ABOVE THE TOTAL FLOW RATE." THE RED TAB IN THE BOLUS IS APPROXIMATELY 1" WIDE, AND ALSO HAS A LARGE WHITE FLAG LABEL WITH RED WRITING THAT STATES "THIS SIDE UP FOR PRIMING. REMOVE RED TAB BEFORE USE." THE DEVICE HISTORY RECORD WAS REVIEWED FOR LOT 772168, AND ALL MANUFACTURING OPERATIONS WERE FOUND TO BE WITHIN SPECIFICATION. A REVIEW OF LOT HISTORY FOUND NO OTHER FAST FLOW COMPLAINTS FOR LOT 772168. IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

Description of Event or Problem · 1

THE RED KEY WAS LEFT IN THE BOLUS ASSEMBLY WHILE THE PUMP WAS BEING USED, CREATING A FAST FLOW. NO ADVERSE EVENT OCCURRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ON-Q C-BLOC	INFUSION PUMP	MEB	I-FLOW CORPORATION	CB005	772168

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other