MAUDE Adverse Event Report: ICU MEDICAL, INC SET EXT 6DIN W/ .2 MICRON FILTER M/M; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 4736062

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/24/2020

Event Type  malfunction  

Event Description

Internal pc only, inbound; spouse reports high pressure alarms on both pumps when using two sets adminstration tubing from lot4736062, after much troubleshooting was able to get pump to run with tubing from recent shipment.Talked to spouse again later, and said no problem with tubing with different lot.No further details provided.Tubing issue.

• Brand Name: SET EXT 6DIN W/ .2 MICRON FILTER M/M
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC
• MDR Report Key: 10487860
• MDR Text Key: 205727279
• Report Number: MW5096414
• Device Sequence Number: 2
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/24/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 4736062
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR