MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC LEVEL 1 TRAUMA FAST FLOW DISPOSABLES; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Catalog Number DI-50

Device Problems Failure to Prime (1492); Priming Problem (4040)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

Only the month (b)(6) and year (2019) of the event date are known.Device evaluation in progress.

Event Description

It was reported that the tubing would not prime at the lowest section of the tubing.The incident occurred prior to use with a patient.There was no patient involvement.

Manufacturer Narrative

One level 1 trauma fast flow disposables sample was received for evaluation from p/n di-50; the sample was received in used condition without its original package.The sample was visually inspected, at a distance of 12" to 24" and normal conditions of illumination and no discrepancies were found.Also, the sample received was tested in the h-1200 fast flow fluid warmer machine in attempted to replicate the failure mode and tubing would not prime.The customer's reported problem was confirmed.According to the investigation, the most probable root cause of the reported problem was that production personnel didn't apply proper solvent.The investigation reported that production personnel was trained in the manufacturing procedure mp d-50 rev.105 to reinforce the correct bonding.The problem source of the reported problem is manufacturing.

• Brand Name: LEVEL 1 TRAUMA FAST FLOW DISPOSABLES
• Type of Device: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9853150
• MDR Text Key: 184069667
• Report Number: 3012307300-2020-02147
• Device Sequence Number: 1
• Product Code: BSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DI-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1