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	Insufficient Information (4580)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.4.Device manufacture 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.
Event or Problem Description
It was reported that bd alaris secondary set fluid back flowed into primary set.The following information was provided by the initial reporter: i have had a recent issue in the chemo suite with a chemo drug not infusing properly to the peripheral line.We are not sure if we are experiencing faulty tubing or faulty phaseal products.Despite being programmed on a pump correctly when started the secondary line was running at a fast rate and it appeared to be infusing up to the primary line (despite clamps being in place) not to the patient.There is now chemo in the primary and secondary line.When we have come across faulty tubing issues previously, we have sent them off to bd for investigation¿.Not sure this is possible in this situation given i have almost a full bag of chemo with patient identifiers on it.I do have packing to ship cytotoxic lines but if we disconnect the iv meds we will encounter staff exposure.Thoughts on how best to report/investigate this issue.________________________________________________________ we do not have any of the original packaging with the products used today so i cannot confirm the lot number, but see below for pictures of the items in question.
Event or Problem Description
It was reported that bd alaris secondary set fluid back flowed into primary set.The following information was provided by the initial reporter: i have had a recent issue in the chemo suite with a chemo drug not infusing properly to the peripheral line.We are not sure if we are experiencing faulty tubing or faulty phaseal products.Despite being programmed on a pump correctly when started the secondary line was running at a fast rate and it appeared to be infusing up to the primary line (despite clamps being in place) not to the patient.There is now chemo in the primary and secondary line.When we have come across faulty tubing issues previously, we have sent them off to bd for investigation¿.Not sure this is possible in this situation given i have almost a full bag of chemo with patient identifiers on it.I do have packing to ship cytotoxic lines but if we disconnect the iv meds we will encounter staff exposure.Thoughts on how best to report/investigate this issue.We do not have any of the original packaging with the products used today so i cannot confirm the lot number.
Additional Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.The customer complaint that there was back flow could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

• 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: 17814709
• Report Number: 9616066-2023-01955
• Device Sequence Number: 19408647
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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: 09/11/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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