FDA Adverse Event Malfunction Summary report: N

HOMEPUMP C-SERIES: 100 ML, 2 ML/HR

MDR report key: 3983139 · Received July 2, 2014

Report

Report Number: 2026095-2014-00105
Event Type: Malfunction
Date Received: July 2, 2014
Report Date: June 4, 2014
Manufacturer: I-FLOW, LLC
Product Code: MEB
PMA / PMN Number: K052117
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

METHOD: THE DEVICES WERE RETURNED FOR AN ANALYSIS. A VISUAL INSPECTION WAS PERFORMED ANDA REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER REPORTED. RESULTS: AT THIS TIME RESULTS ARE PENDING THE COMPLETION OF THE EVALUATION AND INVESTIGATION WHICH IS CURRENTLY ONGOING. PER THE DHR REVIEW, THE LOT MET SPECIFICATIONS AT RELEASE. CONCLUSIONS: ONCE THE ANALYSIS AND INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFORMATION, OR OTHER ANALYSIS AS APPROPRIATE.

Description of Event or Problem · 1

FILL VOLUME: 100 ML. FLOW RATE: 2 ML/HR. PROCEDURE: UNK. CATHPLACE: UNK. REFERENCE 2026095-2014-00106/(B)(4). PUMP 1 OF 2: AN INTERNATIONAL CUSTOMER REPORTED THAT THE INFUSION FROM TWO HOMEPUMPS FINISHED EARLIER THAN EXPECTED. THE INCIDENT AS REPORTED: TWO HOMEPUMPS ENDED SOME HOURS EARLIER (10 HOURS AND 6 HOURS) BEFORE THE THEORETICAL 46 HOURS. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE AND THE QUESTIONAIRE WAS FORWARDED TO THE LIBERAL NURSES PER THE REPORTER. PATIENT INFORMATION AND DATE OF EVENT WERE NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
388378	HOMEPUMP C-SERIES: 100 ML, 2 ML/HR	ELASTOMERIC PUMP	MEB	I-FLOW, LLC	C100020	0201056013

Patients

Seq	Age	Sex	Outcome	Treatment
1				DRUG: 5FU