FDA Adverse Event Malfunction Summary report: N

PROMETRA PROGRAMMABLE PUMP

MDR report key: 6142606 · Received December 2, 2016

Report

Report Number: 3006803715-2016-00191
Event Type: Malfunction
Date Received: December 2, 2016
Date of Event: July 5, 2016
Report Date: November 3, 2016
Manufacturer: FLOWONIX MEDICAL, INC
Product Code: LKK
UDI-DI: 00810335020082
PMA / PMN Number: P080012
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE IS BEING EVALUATED AT THE MANUFACTURING SITE. WHEN THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. INTERNAL COMPLAINT NUMBER: (B)(4).

Additional Manufacturer Narrative · 1

DEVICE EVALUATION: THE DEVICE WAS SUBJECTED TO EXTERNAL AND INTERNAL VISUAL INSPECTION, PRIMING OF THE CATHETER ACCESS PORT, PROGRAMMING OF A DEMAND BOLUS, AND RELEVANT FLOW RATE TESTS. THE EVALUATION DETERMINED THAT THE ISSUE WAS CAUSED BY A PARTIAL OBSTRUCTION OF THE OUTLET VALVE FLOW PATH. THE OBSTRUCTION WAS COMPOSED OF DRUG PRECIPITANTS OF MORPHINE AND BUPIVACAINE. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED ISSUE WAS CONFIRMED. DESCRIBE EVENT OR PROBLEM AND EXPLANT DATE: UPDATED WITH ADDITIONAL INFORMATION. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT A PUMP RESERVOIR VOLUME HIGHER THAN EXPECTED WAS OBSERVED ON MULTIPLE OCCASIONS. A (B)(6) STUDY WAS COMPLETED ON 8/31/2016, AND THE CATHETER WAS LATER FOUND TO BE PATENT. THE DEVICE WAS EXPLANTED, AND THERE WERE NO PATIENT EFFECTS REPORTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT PUMP THERAPY MEDICATION IS MORPHINE AT A DOSAGE OF 4.4 MG/DAY AND BUPIVACAINE AT A DOSAGE OF 4.48 MG/DAY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
792605	PROMETRA PROGRAMMABLE PUMP	IMPLANTABLE INFUSION PUMP	LKK	FLOWONIX MEDICAL, INC	11827		00810335020082

Patients

Seq	Age	Sex	Outcome	Treatment
1