MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 20129E

Device Problem Complete Blockage (1094)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter facility name- (b)(6) specialists.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd alaris extension set was occluded the following information was received by the initial reporter with the following verbatim: item description: tube iv ext w/ filter 1.2 mi lawson# (b)(4).Mfg# 20129e lot# n/a qty: (b)(4).Po #(b)(4).Description of problem: the pump was reading occlusion, i tried trouble shooting prior to placing a new filter onto the tubing.Once the new filter was placed, the pump no longer read occlusion.

Event Description

No additional info.

Manufacturer Narrative

The customer reported that the set occluded.One sample model 20129e was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was attached to a bd primary set and primed with 85% glycerin / 15% water an infusion run was started at a rate of one ml/hr for 24 hrs.There was no observation of fluid blockage.The customer complaint was unable to be replicated.See the attached ¿filtering out the facts: recommendations to optimize performance of in-line filters for parenteral nutrition and intravenous fat emulsion infusions (ivfe)¿ for additional information regarding the use of ivfe with in-line filter administration sets.Although the issue was unable to be replicated and the root cause is unknown bd is looking at opportunities to improve the filter function to alleviate this failure in the future.A device history record review could not be performed because a lot number was not provided by the customer.

• Brand Name: BD ALARIS EXTENSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18603605
• MDR Text Key: 335085775
• Report Number: 9616066-2024-00110
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403234901
• UDI-Public: (01)50885403234901
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 20129E
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1