MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 128" (325 CM) APPX 9.3 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE; PRIMARY IV SET

Catalog Number MC33332

Device Problem Improper Flow or Infusion (2954)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 03/01/2017

Event Type  malfunction  

Manufacturer Narrative

There is no sample available for evaluation.

Event Description

The event involved a customer allegation of a transfer set with microclave dual check valve 0.2 micron filter.It was reported that the micron filter of the device consistently plugs 12-24 hours post initiation of infusion.The involved medication is glucagon with a 1.2% glycerin solution diluent.The glucagon was infused alone with a d5w driver at the y-site.The pressure setting of the pump used (med-fusion) to infuse the glucagon is 12psi on the medium, then would be increased to high at 16psi for most syringe sizes.The pump would begin to high pressure alarm at the 8-10 hour mark after starting with brand new set and would be completely plugged 18-24 hours.On an unknown date in (b)(6) 2017, there was a baby with an unusual diagnosis who required many weeks of glucagon infusions with difficulty with the sets.The patient lost a picc line due to low flow rates directly connected to a filtered infusion set running glucagon.There was patient involvement, but unknown adverse event, unknown medical intervention required and unknown delay in critical therapy.

• Brand Name: 128" (325 CM) APPX 9.3 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE
• Type of Device: PRIMARY IV SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: patricia sharpe-gregg, bsn, rn ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 8341549
• MDR Text Key: 139359536
• Report Number: 9617594-2019-00039
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MC33332
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1