MAUDE Adverse Event Report: ICU MEDICAL VALVE ACCESSORIES

Device Problems Bent (1059); Insufficient Flow or Under Infusion (2182); Physical Resistance (2578)

Patient Problem Underdose (2542)

Event Date 06/30/2016

Event Type  Injury  

Event Description

Initially rolled the cadd solis vip ambulatory pumps out to our patients, after months of device problems and lack of complaint/device corrections.We had to go with a smiths straight set 7322 with addon filter and antisiphon valve as the smiths sets with inline filters consistently had air in the lines below the filter (reported, still waiting for rca results/correction).We immediately had multiple and frequent reports of underinfusion.Some were attributed to bending in the addons, and was corrected.A portion was attributable to the increased resistance of the add-ons.It just wasn't working on patients (not even close to our lab/tabletop results reported in previous installment).The majority were reported - so many, had to report in batches.The flowstop's "recall" came out - the flowstop technology as used in the 7322 contributed to additional underinfusion - but there was insufficient product produced by smiths to undertake an actual recall, so our staff and patients just had to continue to use the defective sets.The underinfusions were unacceptable, and the desired sets but that had air in lines weren't corrected yet, so we decided to go with a non-flowstop set, this simmer (7036).The story of leaking 7036 sets, and the poor complaint handling/quality system/capa/communication will be my next installment.Submitted 41 reports (originally miscounted as 56) serious underinfusions, #7322 plus addons.(b)(6) - submitted 11 reports serious underinfusions set 7036; 3 reports 7322 and add-ons.More reported and submitted.Sticky drugs were the very worst.We had several underinfusions between 15 percent to 56 percent, where patients were compromised and needed additional care.All patients required much higher levels of monitoring; we had to develop a unique form to calculate the amount of drug underinfused for every patient every visit, get the doc to intervene as needed etc.

• Brand Name: VALVE ACCESSORIES
• Type of Device: VALVE
• Manufacturer (Section D): ICU MEDICAL
• MDR Report Key: 6198061
• MDR Text Key: 63223381
• Report Number: MW5066840
• Device Sequence Number: 0
• Product Code: FPB
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/20/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/30/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention