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

Catalog Number	11448964
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd alaris secondary set emptied its content into the primary bag when the infusion was paused.The following information was provided by the initial reporter: secondary medication hung and programmed to run with a vtbi of 31ml (+25ml flush) at a rate of 124ml/h (over 15 minutes), but medication infused much more quickly with the volume in the bag decreasing rapidly over a couple minutes.When the pump was paused the medication continued to infuse until line clamped.The charge nurse also notes that the primary bag started emptying rapidly after the secondary bag.Appears to be a primary set bcv failure.Biomed findings so far (from facility): obtained the error and event logs to both the lvp and the pcu.Error logs indicate a history of patient side occlusions due to a very low voltage on the patient-side pressure sensor.There is nothing to indicate that this was significant to the problem at hand.Used the logs to replicate the infusion settings for biomed testing.No issues with how user programmed device.One way valve on the primary tubing seems to be broken as it is letting fluids through both directions (after occluding the patient side).When the patient side is occluded, the secondary is still dripping, however, the fluid goes through the primary tubing to the drip chamber, and ultimately to the primary bag.(using gravity).Confirmed the secondary bag emptied its content into the primary bag when the infusion was paused.No harm, but potential for harm if different medication.
Additional Manufacturer Narrative
This complaint was opened for the concomitant sample of pr8634380.The samples that arrived were tested under pr8634380.There is no issue with the concomitant sample.A dhr was not performed as the lot number is "unknown" for the primary suspect sample of this complaint.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
No additional information.Material#:11448964, batch#: unknown.Secondary medication hung and programmed to run with a vtbi of 31ml (+25ml flush) at a rate of 124ml/h (over 15 minutes), but medication infused much more quickly with the volume in the bag decreasing rapidly over a couple minutes.When the pump was paused the medication continued to infuse until line clamped (mms pump pr8627530).The charge nurse also notes that the primary bag started emptying rapidly after the secondary bag.Appears to be a primary set bcv failure.Biomed findings so far: obtained the error and event logs to both the lvp and the pcu (see attached).Error logs indicate a history of patient side occlusions due to a very low voltage on the patient-side pressure sensor.There is nothing to indicate that this was significant to the problem at hand.Used the logs to replicate the infusion settings for biomed testing.No issues with how user programmed device.One way valve on the primary tubing seems to be broken as it is letting fluids through both directions (after occluding the patient side).When the patient side is occluded, the secondary is still dripping, however, the fluid goes through the primary tubing to the drip chamber, and ultimately to the primary bag.(using gravity).Confirmed the secondary bag emptied its content into the primary bag when the infusion was paused.

• Brand Name: BD ALARIS SECONDARY SET
• Common Device Name: 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17607969
• Report Number: 9616066-2023-01784
• Device Sequence Number: 6139424
• Product Code: FPA
• UDI-Device Identifier: 50885403234741
• UDI-Public: (01)50885403234741
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K790582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2023

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 Catalogue Number: 11448964
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown