MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. BD IV FILTER; INTRAVASCULAR SET FILTER

Model Number SPEC18212

Device Problems Complete Blockage (1094); Restricted Flow rate (1248)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the unspecified bd filter was clogged/blocked/occluded.The following information was provided by the initial reporter: the following is the summary of what happened with the pump: ¿on (b)(6) 2020 a iomab-b therapeutic infusion was performed for patient with a filter in the infusion line.The alaris pump alarmed shortly after starting the infusion, which is common based on clamping the lines, and the team was able to address the alarm and proceed with the infusion.Within approximately 30 minutes the pump alarmed again, and alarms continued to occur despite the team trying to resolve the source of the issue.The clinical site staff evaluated the issue and suspected the additional filter to be the source of the problem.The infusion was paused, a second filter was carefully back-primed and the original filter and the infusion restarted.The alarms continued and were becoming more frequent.After filter removal the patient was infused without further pump alarms¿.Can you please provide in details as to what really happened when the pump alarmed.What message did the alarm show (error code/message)? did the pump shut off (battery issue)? according to our clinical site, ¿occluded¿ was the alarm readout.Was there any effects caused to the patient as a result of the event? any patient impact? -the patient was infused.There was no patient impact.No saes reported.Can you please provide patient information/demographic? (weight, sex, age, diagnosis) -we can¿t provide this information due to confidentiality.What was infusing into the pump? -iomab-b therapeutic dose.

Manufacturer Narrative

The following was corrected with additional information: d4.Model# and material#: spec18212.D4.Lot#: customer provided ncmiob200721-01-td1, but it did not match our records.No product or photo was returned by the customer.It was reported that the pump would not infuse while using the pump with the filter.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model: spec18212 because an invalid lot number was provided by the customer.A device history record review could not be performed on model: 24001-0007 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.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the unspecified bd filter was clogged / blocked / occluded.The following information was provided by the initial reporter: the following is the summary of what happened with the pump: ¿on (b)(6) 2020 a iomab-b therapeutic infusion was performed for patient with a filter in the infusion line.The alaris pump alarmed shortly after starting the infusion, which is common based on clamping the lines, and the team was able to address the alarm and proceed with the infusion.Within approximately 30 minutes the pump alarmed again, and alarms continued to occur despite the team trying to resolve the source of the issue.The clinical site staff evaluated the issue and suspected the additional filter to be the source of the problem.The infusion was paused, a second filter was carefully back-primed and the original filter and the infusion restarted.The alarms continued and were becoming more frequent.After filter removal the patient was infused without further pump alarms¿.1.Can you please provide in details as to what really happened when the pump alarmed.What message did the alarm show (error code / message)? did the pump shut off (battery issue)? according to our clinical site, ¿occluded¿ was the alarm readout.2.Was there any effects caused to the patient as a result of the event? any patient impact? the patient was infused.There was no patient impact.No saes reported.A.Can you please provide patient information/demographic? (weight, sex, age, diagnosis) we can't provide this information due to confidentiality.B.What was infusing into the pump? iomab-b therapeutic dose.

• Brand Name: BD IV FILTER
• Type of Device: INTRAVASCULAR SET FILTER
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.; blvd. insurgentes 20351; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10519620
• MDR Text Key: 233926872
• Report Number: 9616066-2020-02755
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SPEC18212
• Device Catalogue Number: SPEC18212
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEC TUBING,PRI TUBING, 20200723; SEC TUBING,PRI TUBING, 20200723
• Patient Outcome(s): Other