MAUDE Adverse Event Report: CAREFUSION MAXGUARD EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

Model Number	MFS106
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.Patient demographics requested.
Event or Problem Description
It was reported that the extension set used during an unspecified infusion infused faster than expected.The facility performed an internal test using a saline 1 liter programmed to infuse at 250 ml/hr.Over 4 hrs.However infused under 3 hrs.The customer reported no patient harm.
Additional Manufacturer Narrative
Received from the customer is one out of package extension set model mfs106 lot unknown.The customer did not send in the suspect extension set or connecting gravity set that was reported for this event.The customer¿s report that the flow regulator was infusing fluid too quickly was not confirmed.Visual inspection did not find any anomalies.Functional gravity infusion of 1000 ml over 4 hours was successful with no instances infusing too quickly observed.The extension sets flow rate controller was received set at 250 ml/hr.Gravity infusion testing was performed by attaching a lab iv bag filled with 1000ml of blue dye water to the lab gravity set.The gravity infusion was set to 250ml/hr.And vtbi 1000ml to be run over 4 hours just as the customer reported.The infusion was checked periodically and successfully finished on time at 4 hours later with all the fluid being infused.The root cause could not be determined.
Event or Problem Description
Revised: it was reported the user initiated testing on the flow regulator as one of the lhin (local health integration network) areas was infusing fluids too quickly.The rn conducted an internal test on (b)(6) 2019.The flow regulator was connected to a gravity iv tubing and a 1 liter bag of normal saline (both were baxter products).The normal saline infusion (1l) was programmed at a rate of 250 ml/hr.Over 4hrs at 9am however it was completed by 11:55 am.There was no patient involvement, the event occurred during an internal test.

• Brand Name: MAXGUARD EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8609263
• Report Number: 9616066-2019-01363
• Device Sequence Number: 16717905
• Product Code: FPA
• UDI-Device Identifier: 10885403236358
• UDI-Public: 10885403236358
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2024
• Device Model Number: MFS106
• Device Catalogue Number: MFS106
• Device Lot Number: 19025376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRIMARY TUBING; PRIMARY TUBING