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

Model Number 72213N

Device Problems Backflow (1064); Free or Unrestricted Flow (2945)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2022

Event Type  malfunction  

Event Description

It was reported that the bd alaris¿ secondary set had flow issues with potassium dripping into the secondary tubing drip chamber despite not being initiated.The following information was provided by the initial reporter: "utilized established primary/secondary tubing to administer iv potassium to patient.Backflushed secondary iv tubing that had previously been used for zosyn.Piggybacked potassium to ns bag that was infusing kvo rate at the time.Observed the potassium immediately began rapidly dripping into secondary tubing drip chamber despite infusion not yet being initiated on ivac.Noted fluid level rising in drip chamber of primary tubing.Immediately closed roller clamp to primary tubing.Clamped roller clamp for secondary tubing.Noted that tubing appeared to be setup according to facility policy, including extension hook for primary bag being fully extended, and iv pole raised to appropriate height above ivac.Disconnected primary tubing from patient iv.Set up new primary/secondary tubing with new bag of ns for primary tubing.Obtained new bag of potassium.Equipment set up in usual fashion per facility policy.Observed the potassium immediately began dripping into secondary tubing drip chamber despite infusion not yet being initiated on ivac.Noted fluid level rising in drip chamber of primary tubing.Primary tubing was not yet connected to patient.Tubing was removed from iv pole and placed into market plastic bag, separate from bag used for 1st set of discarded iv tubing.".

Manufacturer Narrative

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.

Manufacturer Narrative

Investigation summary: no product or photo was returned by the customer.It was reported that the tubing back flashed.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 72213n because a lot number was unknown.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

Event Description

It was reported that the bd alaris¿ secondary set had flow issues with potassium dripping into the secondary tubing drip chamber despite not being initiated.The following information was provided by the initial reporter: "utilized established primary/secondary tubing to administer iv potassium to patient.Backflushed secondary iv tubing that had previously been used for zosyn.Piggybacked potassium to ns bag that was infusing kvo rate at the time.Observed the potassium immediately began rapidly dripping into secondary tubing drip chamber despite infusion not yet being initiated on ivac.Noted fluid level rising in drip chamber of primary tubing.Immediately closed roller clamp to primary tubing.Clamped roller clamp for secondary tubing.Noted that tubing appeared to be setup according to facility policy, including extension hook for primary bag being fully extended, and iv pole raised to appropriate height above ivac.Disconnected primary tubing from patient iv.Set up new primary/secondary tubing with new bag of ns for primary tubing.Obtained new bag of potassium.Equipment set up in usual fashion per facility policy.Observed the potassium immediately began dripping into secondary tubing drip chamber despite infusion not yet being initiated on ivac.Noted fluid level rising in drip chamber of primary tubing.Primary tubing was not yet connected to patient.Tubing was removed from iv pole and placed into market plastic bag, separate from bag used for 1st set of discarded iv tubing.".

• Brand Name: BD ALARIS¿ SECONDARY SET
• Type of Device: 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 ; 8015296192
• MDR Report Key: 13499445
• MDR Text Key: 285633739
• Report Number: 9616066-2022-00097
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203010078
• UDI-Public: 07613203010078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2022

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
• Device Operator: Other
• Device Model Number: 72213N
• Device Catalogue Number: 72213N
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/09/2022
• Supplement Dates Manufacturer Received: 02/16/2022
• Supplement Dates FDA Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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