FDA Adverse Event Other Summary report: N

ECLIPSE

MDR report key: 1074658 · Received July 10, 2008

Report

Report Number: 2026095-2008-00083
Event Type: Other
Date Received: July 10, 2008
Date of Event: June 1, 2008
Report Date: June 12, 2008
Manufacturer: I-FLOW CORPORATION
Product Code: MEB
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER AND THE EVALUATION OF THE SAMPLES SUBMITTED. FOUR SAMPLES WERE RECEIVED FOR EVALUATION AND INVESTIGATION. THE FILL VOLUME WAS CONFIRMED TO BE 150ML, WHICH IS BELOW THE MINIMUM FILL VOLUME FOR THIS PUMP OF 200ML. THE NOMINAL FILL VOLUME IS 400ML. THE UNDERFILL OF THE PUMPS CAUSED THE PUMPS TO FLOW QUICKLY. THE DIRECTIONS FOR USE (DFU) CONTAIN A CAUTION FOR UNDERFILLING THE PUMP: "CAUTION: FILLING THE PUMPS LESS THAN NOMINAL RESULTS IN FASTER FLOW RATE." THE PUMPS RETURNED WERE FILLED WITH NORMAL SALINE SOLUTION TO THE NOMINAL FILL VOLUME OF 400ML, AND A FLOW RATE ACCURACY TEST WAS PERFORMED. THE PUMPS WERE FUNCTIONED WITHIN SPECIFICATION. FROM THE INFORMATION PROVIDED, THE CAUSE OF THIS INCIDENT WAS USER ERROR IN UNDERFILLING THE PUMPS. IN ADDITION, RETAINED DEVICES FROM LOT 822277 WERE TESTED FOR FLOW RATE ACCURACY. AT THE NOMINAL FILL VOLUME OF 400 ML, THE AVERAGE FLOW RATE WAS WITHIN SPECIFICATION. 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

PUMPS INFUSED IN HALF THE TIME AND PATIENT HAD SYMPTOMS OF REDMAN'S, BUT WAS NOT HOSPITALIZED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ECLIPSE	INFUSION PUMP	MEB	I-FLOW CORPORATION	E401000	822277

Patients

Seq	Age	Sex	Outcome	Treatment
1	29 YR		Other