MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS PUMP MODULE SMARTSITE INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2420-0500

Device Problem Backflow (1064)

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

Event Date 12/16/2023

Event Type  malfunction  

Event Description

It was reported that bd alaris pump module smartsite infusion set had flow issues the following information was received by the initial reporter with the following verbatim: incidents: a tubing failure where the backflow valve allowed the secondary tubing (potassium) to flow back into primary iv bag.Began an iv piggyback infusion of 10 meq potassium/100ml bag as a secondary to a line formerly being used as a kvo, running at 100ml/hr as per guardrails.Roughly half an hour later, i noticed the potassium bag and secondary line were completely dry.The pump showed 100ml/hr rate and 50ml infused and 50ml remaining, despite the bag being empty.I triple checked with two other nurses that the line setup and pump were correct.No alarms had sounded.Immediately discontinued that channel and brain from use.Used the primary bag again on another pump/channel, and later noticed the same issue after roughly 40 minutes- potassium bag was empty, but pump (still running at 100ml/hr) said it only infused 85ml with 15ml remaining (i backfilled the secondary line from the primary specifically to keep that from affecting the total volume).Discontinued that pump/channel as well.Called pharmacy to see if there were ever any reports of potassium bags being underfilled.Pharmacy weighed the bags in question to known good, and they appeared full.Upon testing the primary line, it appears the backflow valve was malfunctioning and the secondary potassium bag was somehow filling the primary bag.Verified by using the original channel/pump with separate tubing (all correct amounts went into graduated cylinder) and again with the original 'problem' tubing' which delivered the correct amount through the pump, but the secondary bag was drained (obviously into primary bag, as no other leaks possible).All other possibilities eliminated, only answer is that the backflow valve in this particular primary tubing set was malfunctioning.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Manufacturer Narrative

No product or photo was returned by the customer.The customer complaint of flow issues - back flow could not be verified due to the product not being returned for failure investigation.A device history record review for material# 2420-0500 and lot# 23085535 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

Event Description

No additional info.

Manufacturer Narrative

No product or photo was returned by the customer.The customer complaint of flow issues - back flow could not be verified due to the product not being returned for failure investigation.A device history record review for material# 2420-0500 and lot# 23085535 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 18aug2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

Event Description

No additional info.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE INFUSION 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18490040
• MDR Text Key: 332995241
• Report Number: 9616066-2023-02514
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203012448
• UDI-Public: (01)37613203012448
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2420-0500
• Device Lot Number: 23085535
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1