MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ LVP 20D 3SS CV BV; INTRAVASCULAR ADMINISTRATION SET

Model Number 11522558

Device Problems Complete Blockage (1094); Air/Gas in Device (4062)

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

Event Date 08/05/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.

Event Description

It was reported that the bd alaris¿ lvp 20d 3ss cv bv experienced blockage.The following information was provided by the initial reporter: i am hearing awful stories of nicu nurses not being able to prime the tubing and also having to use 2-3 sets for something b2141 only needed one for.

Event Description

It was reported that the bd alaris¿ lvp 20d 3ss cv bv experienced air in line.The following information was provided by the initial reporter: i am hearing awful stories of nicu nurses not being able to prime the tubing and also having to use 2-3 sets for something b2141 only needed one for.

Manufacturer Narrative

The following fields were updated due to additional information: b5: it was reported that the bd alaris¿ lvp 20d 3ss cv bv experienced air in line.H6: imdrf annex a grid: a1415 investigation summary three samples (model #11522558) were returned from the customer along with pages not what happened with each sample.Based on the returned pages, it was reported that chemo tubing drew air.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The sets were each primed successfully with saline.After priming, the sets were drained to see where the ball would land.For each set, the ball landed where it should at the bottom of the drip chamber and did not allow air in the line.The failure was unable to be replicated, and the complaint could not be verified.A root cause was unable to be determined because the failure was unable to be replicated.A device history record review could not be performed on model 11522558 because a lot number is unknown.

• Brand Name: BD ALARIS¿ LVP 20D 3SS CV BV
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15332427
• MDR Text Key: 305373813
• Report Number: 9616066-2022-01262
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403232303
• UDI-Public: 50885403232303
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 11522558
• Device Catalogue Number: 11522558
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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