MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD ALARIS¿ PRIMARY SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problem Obstruction of Flow (2423)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 02/09/2023

Event Type  Injury  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in report.And the franklin lakes fda registration number has been used for the manufacture report number.Medical 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 alaris¿ primary set was blocked during the infusion.As a result, the patient required titration of norepinephrine until a new norepinephrine line could be mixed and hung.The following information was provided by the initial reporter: "a psls event was reported regarding an alaris pump not alarming for a patient receiving a norepinephrine infusion involving a pump (15921996) and channel (14057561) rn trouble shooting issue and noted infusion was not dripping.Alaris pump did not alarm and gave no indication that fluid was not being delivered.Iv tubing removed from channel and on inspection it was noted that tubing appeared to be fused together inside channel.What additional medical intervention was provided to the patient because of the event? (e.G., titration of norepinephrine, administration of extra fluids and/or additional medication): titration of norepinephrine until new line of norepinephrine could be mixed and hung.What was the patient¿s outcome? no harm".

Event Description

It was reported that the unspecified bd alaris¿ primary set was blocked during the infusion.As a result, the patient required titration of norepinephrine until a new norepinephrine line could be mixed and hung.The following information was provided by the initial reporter: "a psls event was reported regarding an alaris pump not alarming for a patient receiving a norepinephrine infusion involving a pump (b)(6) and channel (b)(6) rn trouble shooting issue and noted infusion was not dripping.Alaris pump did not alarm and gave no indication that fluid was not being delivered.Iv tubing removed from channel and on inspection it was noted that tubing appeared to be fused together inside channel.What additional medical intervention was provided to the patient because of the event? (e.G., titration of norepinephrine, administration of extra fluids and/or additional medication): titration of norepinephrine until new line of norepinephrine could be mixed and hung.What was the patient¿s outcome? no harm".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 17-apr-2023.H6: investigation summary: one sample model 10010483 was returned for investigation.The set was examined for defects and abnormalities.The tubing was fused at the silicone segment.The customer¿s returned set model #10010483 was observed to be fused where the pumping segment lines up with the upper and lower occluder fingers.After massaging the fused segments open, functional testing of the administration set showed no anomalies.Fused tubing is the result of leaving tubing in the pumping chamber for an extended period of time and can result in a vacuum leading to no infusion therapy provided, and no occlusion detection alarm indication.The pump chamber blocked tip sheet (dir (b)(6)) instructs the user as follows: cause: if the tubing inside the pump is held under fixed compression for a prolonged period of time, it will fuse closed on occasion.A device history record review could not be performed because a lot number was not provided by the customer.

• Brand Name: UNSPECIFIED BD ALARIS¿ PRIMARY SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16503875
• MDR Text Key: 310911228
• Report Number: 2243072-2023-00327
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• 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
• Patient Outcome(s): Required Intervention