FDA Adverse Event Malfunction Summary report: N

MERIT MANIFOLD

MDR report key: 1880890 · Received October 4, 2010

Report

Report Number: 1721504-2010-00301
Event Type: Malfunction
Date Received: October 4, 2010
Date of Event: September 9, 2010
Report Date: September 9, 2010
Manufacturer: MERIT MEDICAL SYSTEMS, INC.
Product Code: DQO
PMA / PMN Number: K913161
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION: THE DEVICE EVALUATION/INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SENT WHEN THE EVALUATION IS COMPLETED. EVAL: CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

Description of Event or Problem · 1

THE MANIFOLD USED ON A HEART PATIENT DURING SURGERY WAS LEAKING RESULTING IN THE PATIENT NOT RECEIVING THE FULL AMOUNT OF MEDICATION. THIS RESULTED IN A DECREASE IN THE PATIENT'S BLOOD PRESSURE. THE PATIENT DID NOT REQUIRE ADDITIONAL MEDICATION OR TREATMENT. THE DEVICE WAS CHANGED WITH ANOTHER AND PATIENT'S BLOOD PRESSURE RETURNED TO EXPECTED MEDICATED LEVEL. THE MANIFOLDS ARE USED WITH VARIOUS MEDICATIONS IN THE OPERATING ROOM AND ICU. NO HARM OR INJURY REPORTED. THE CUSTOMER REPORTED THIS HAS OCCURRED WITH SIX (6) DIFFERENT MANIFOLDS OVER THE PAST MONTH. THE CUSTOMER DID NOT PROVIDE CLINICAL INFORMATION FOR THE ADDITIONAL FIVE EVENTS. THIS EVENT IS REPORTED AS LIFE THREATENING ADVERSE EVENT. THE ADDITIONAL EVENTS ARE REPORTED AS A PRODUCT PROBLEM. THIS IS ONE OF SIX REPORTS. 1721504-2010-00302, 1721504-2010-00303, 1721504-2010-00304, 1721504-2010-00305, 1721504-2010-00306.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MERIT MANIFOLD	CATHETER, INTRAVASCULAR, DIAGNOSTIC	DQO	MERIT MEDICAL SYSTEMS, INC.		H120584

Patients

Seq	Age	Sex	Outcome	Treatment
1			Life Threatening	LIPID INFUSIONS\| VARIOUS MEDICATIONS USED IN OPEARTING RM & ICU\| DOPAMINE