MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ LVP 20D 2SS CV; INTRAVASCULAR ADMINISTRATION SET

Model Number 2420-0007

Device Problem Misassembled (1398)

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

Event Date 07/23/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.

Event Description

It was reported that the bd alaris¿ lvp 20d 2ss cv experienced roller clamp missing from iv tubing.The following information was provided by the initial reporter: "iv tubing found to not have roller clamp on it during line change.".

Manufacturer Narrative

The following fields were updated due to additional information: possible lots d4: medical device lot #: 22045599; d4: medical device expiration date: 07apr2025 ; h4: device manufacture date: 07apr2022.D4: medical device lot #: 22045695; d4: medical device expiration date: 08apr2025; h4: device manufacture date: 08apr2022.D4: medical device lot #: 22045694; d4: medical device expiration date: 07apr2025 ; h4: device manufacture date: 07apr2022.D4: medical device lot #: 22045754; d4: medical device expiration date: 09apr2025; h4: device manufacture date: 09apr2022.D4: medical device lot #: 22045696; d4: medical device expiration date: 08apr2025; h4: device manufacture date: 08apr2022.D4: medical device lot #: 22045747; d4: medical device expiration date: 11apr2025; h4: device manufacture date: 11apr2022.H6: investigation summary : a complaint of a set being misassembled was received from the customer.A sample was returned for investigation.Through visual inspection, misassembly was not confirmed as the sample did have a roller clamp.However, separation was seen at the lower part of the pumping segment.No ring was seen but an indent of where the ring would be can be seen on the tubing.Possible lots were determined using the smart site ids.A device history record review for model 2420-0007, lot number 22045599 was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 07apr2022.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 22045695 was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 08apr2022.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 22045694 ,was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 07apr2022.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 22045754, was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 09apr2022.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 22045696, was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 08apr2022.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 22045747, was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 11apr2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause could not be determined as misassembly was not observed.A root cause could not be determined as misassembly was not observed.The manufacturing site was notified of the separation defect.After review of the assembly process and consideration of the controls that exist , the potential root cause of the separation is not related to the manufacturing process.This is also confirmed with evidence that the ring retainer was assembled onto the set.The root cause is unknown.

Event Description

It was reported that the bd alaris¿ lvp 20d 2ss cv experienced roller clamp missing from iv tubing.The following information was provided by the initial reporter: "iv tubing found to not have roller clamp on it during line change.".

• Brand Name: BD ALARIS¿ LVP 20D 2SS CV
• 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: 15255048
• MDR Text Key: 302520122
• Report Number: 9616066-2022-01191
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021020
• UDI-Public: 37613203021020
• 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: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• 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