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

Catalog Number 2420-0007

Device Problems Defective Component (2292); Chemical Problem (2893)

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

Event Date 01/08/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that unspecified bd infusion set check valve malfunction the following information was received by the initial reporter with the following verbatim: hello, we¿ve had another back-check valve failure here at cvh, at 2:45pm (b)(6) in 3d.This time i created the psls report myself.The psls event id is: (b)(4).I¿ve obtained images of the backcheck failure (see attached).Testing on the device isn¿t complete yet, but since the backcheck valve failure is visible from fluid ingress and the only indication of a problem, the pump itself is not super relevant.No relevant errors in the logs for either device.I¿ll send the error logs and event logs to bd soon.Summary patient was being infused with ferric derisomaltose (monoferric).Intended dose: 1000mg/10ml (10ml inj) using a secondary bag.Primary bag contained 0.9% nacl.The equipment used was a bd carefusion alaris pump, assets 104472 and 100190.During infusion, nurses noticed that the dark red ferrous injection was creeping past the back-check valve on the secondary line and alerted biomed.Biomed gathered photo evidence and it was decided to allow the infusion to complete because the amount of fluid moving past the valve was small.No patient harm occurred.The entire iv setup, including bags and line, were retrieved unaltered once the infusion was complete.Unfortunately the packaging had already been disposed of so the lot number is unknown.Will send the iv set to bd.

Manufacturer Narrative

The customer reported that there was back flow.One sample was returned for investigation.The set was examined for defects and abnormalities.It was observed that the medication that was left in the set started to go up the secondary set.No other defects or abnormalities were observed.The primary set was primed with saline and the secondary set was primed with blue dye water.The set-up was allowed to free flow and there was no observation of back flow.The primary set was then clamped and back flow was observed.The customer complaint was verified and a quality notification was sent to the supplier.The sample was lost on transit to the supplier.If the sample arrives at the supplier the investigation will be reopened.The root cause could not be determined because the sample was lost in transit to the supplier.A dhr was performed for the possible lots 23105502, 23105503: a device history record review for model 2420-0007 lot number 23105502 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.A device history record review for model 2420-0007 lot number 23105503 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.

Event Description

No additional info.

• Brand Name: UNSPECIFIED BD 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: 18592974
• MDR Text Key: 335076315
• Report Number: 9616066-2024-00088
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: (01)07613203021012
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K221327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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 Catalogue Number: 2420-0007
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/28/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1