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

Catalog Number	C25012
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
It was reported that the bd alaris extension set experienced underinfusion.There was no report of patient impact.The following information was provided by the initial reporter: no alarms, the bags are filled with around 521ml, then about 40ish ml of overfill.We run them at about 23-25ml/hr for 24hrs.A few bags a month ago ran 5 and 7 hours over! no alarms, no air in line alerts.The pump stated it infused 740ml.We filled those bags of saline down in pharmacy to trouble shoot, we couldn¿t even put that much saline in the bags.We had our biomed team troubleshoot the alaris pump and it was found to be calibrated properly.This is the only other step i can think of.Was there any impact or harm due to the reported issue? chemotherapy did not infuse over allotted time of 24 hours.
Event or Problem Description
It was reported that the bd alaris extension set experienced underinfusion.There was no report of patient impact.The following information was provided by the initial reporter: no alarms, the bags are filled with around 521ml, then about 40ish ml of overfill.We run them at about 23-25ml/hr for 24hrs.A few bags a month ago ran 5 and 7 hours over! no alarms, no air in line alerts.The pump stated it infused 740ml.We filled those bags of saline down in pharmacy to trouble shoot, we couldn¿t even put that much saline in the bags.We had our biomed team troubleshoot the alaris pump and it was found to be calibrated properly.This is the only other step i can think of.¿ was there any impact or harm due to the reported issue? chemotherapy did not infuse over allotted time of 24 hours.
Additional Manufacturer Narrative
H6: investigation summary: a photo of the extension set connected to other unidentified sets was provided by the customer.The customer complaint of flow issues - accuracy could not be verified from the photo received.A device history record review could not be performed because the lot number is unknown.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

• Brand Name: BD ALARIS EXTENSION 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16527232
• Report Number: 9616066-2023-00418
• Device Sequence Number: 16809735
• Product Code: FPA
• UDI-Device Identifier: 10885403235610
• UDI-Public: (01)10885403235610
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2023

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: Other
• Device Catalogue Number: C25012
• 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: 02/13/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 03/12/2023
• Supplement Report FDA Received Date: 03/27/2023
• 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