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

Catalog Number 30832

Device Problems Complete Blockage (1094); Restricted Flow rate (1248)

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

Event Date 09/28/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 21065258.Medical device expiration date: 2024-06-02.Device manufacture date: 2021-06-02.Medical device lot #: medical device expiration date: 2023-07-29.Device manufacture date: 2020-07-29.Investigation summary: 20076324.A 30832 product was not available for investigation; however the customer confirmed that the complaint samples were from lot 21065258 and lot 20076324.No further information was available to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 20076324 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.However, a review of the production records for lot 21065258 identified that occlusions were identified during in-process testing at the y-site joint, however in this instance without additional information about the exact location of the occlusion it could not be determined if this may have contributed to the customer¿s experience.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the 30832 product over the past 12 months.

Event Description

It was reported that 2 bd alaris¿ pca sets experienced flow issues and were clogged.The following information was provided by the initial reporter: problems have been encountered with the tubing.When connector a is used the liquid can be injected easily, when connector b is used a lot of force has to be applied and it is very difficult to let the liquid flow through the line.

Event Description

It was reported that 2 bd alaris¿ pca sets experienced flow issues and were clogged.The following information was provided by the initial reporter: problems have been encountered with the tubing.When connector a is used the liquid can be injected easily, when connector b is used a lot of force has to be applied and it is very difficult to let the liquid flow through the line.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 11/19/2021 h.6.Investigation: two 30832 products were received for investigation in opened packaging from lot 21065258 and lot 20076324; residual fluid was present in both products.No connecting products were received to assist the investigation.Functional testing involved flushing fluid through both lines of the 30832 sets; no occlusion was observed in either product, however it was confirmed that flow was more restricted in the infusion line without the back check valve (bcv) than the line with the bcv.The tubing was then cut apart and it was noted that the tubing of the infusion line without the bcv was microbore, whereas the tubing with the bcv was a standard bore.The details of this feedback were forwarded to the manufacturing site for investigation.They confirmed that the product is designed to be manufactured with tubing of differing internal lumen sizes, no manufacturing defects were observed to the returned samples which may have contributed to the customer's experience.Dhr's were performed, 2 qn's were noted with lot# 21065258 and 0 with 20076324.The qn's are as follows.1.Issue is backflow.Not related to issue reported.2.This was an occlusion issue.The occlusion was found in the y-site generated by excess of solvent.

• Brand Name: BD ALARIS¿ PCA 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12701277
• MDR Text Key: 278562758
• Report Number: 9616066-2021-52311
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 30832
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2021
• 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