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

Model Number 10015861A

Device Problem Leak/Splash (1354)

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

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 bd alaris¿ pump module administration sets had an issue with leakage.The following information was provided by the initial reporter: "last night, we received a call from nursing stating there was leaking at the y-site port.".

Event Description

It was reported bd alaris¿ pump module administration sets had an issue with leakage.The following information was provided by the initial reporter: "last night, we received a call from nursing stating there was leaking at the y-site port".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 10/25/2021.H.6.Investigation: a sample of an unknown lot was returned for investigation.Through visual inspection, no defects or damages were noticed on the set.During priming, leakage was not observed.When the set was infused, leakage was seen at the y-site port of the drip chamber.The customer complaint was confirmed.A small cut could be seen on the blue piece of the smartsite.Potential lots were provided by the customer.Dhr was performed on the three provided lots.A device history record review for model 10015861a lot number 21046331 was performed.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 10015861a lot number 21046330 was performed.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 could not be performed for model 10015861a lot number 20056213 because this lot belongs to a different material number.(mat: mx9128) the root cause for this defect was determined to be a manufacturing issue.

• Brand Name: BD ALARIS¿ PUMP MODULE ADMINISTRATION SETS
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12682823
• MDR Text Key: 278127257
• Report Number: 9616066-2021-52295
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403232624
• UDI-Public: 50885403232624
• 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: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10015861A
• Device Catalogue Number: 10015861A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2021
• 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