MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. MAXPLUS POSITIVE PRESSURE CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MP1000 CHINA

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a sample was not available for investigation of this feedback; however the customer indicates that the piston component was missing from the maxplus device.Investigation conclusion: the details of this feedback were forwarded to the manufacturing site for investigation.Previous similar investigations have confirmed that the maxplus component is assembled by an automatic assembly machine which is capable of detecting and automatically segregating any maxplus components which are deemed to have not been correctly assembled.In addition to this the products are visually inspected for such defects following assembly.In this instance it is possible that the misassembled component was not detected by the assembly machine due to a misaligned valve detection system, and the affected component was not detected during subsequent inspections prior to continuing on to further assembly steps.A review of the production records for lot 15128105 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The quality team at the manufacturing site has been informed of this complaint in order to be aware of the reported failure mode during future production of this product.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the maxplus device in the past 12 months.Root cause analysis: here¿s the dhr for the affected lot: pr: (b)(4), lot: 15128105 , model: mp1000 china , qty: (b)(4), qn/deviation: none , mfg date: 31-dec-2015.Mp1000 china this is an international code- the model#/catalog# identified is a carefusion product which is same or similar to a device that is approved for sale domestically.The domestic similar list number is mp1000.The 510k number provided is for the domestic similar product.(b)(4).

Event Description

It was reported that the maxplus positive pressure connector experienced unregulated flow.The following information was provided by the initial reporter: the valve was missing while changing the connector for the patient, so it was replaced immediately the sample couldn¿t be returned.Customer response letter wasn¿t needed.

• Brand Name: MAXPLUS POSITIVE PRESSURE CONNECTOR
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.; blvd. insurgentes 20351; tijuana, null 22244 ; MX 22244
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 s state st; sandy UT 84070 3213
• Manufacturer Contact: brett wilko ; 9450 s state st; sandy, UT 84070-3213 ; 8015652341
• MDR Report Key: 10049641
• MDR Text Key: 209391047
• Report Number: 9616066-2020-01483
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: MP1000 CHINA
• Device Lot Number: 15128105
• Was Device Available for Evaluation?: No
• Date Device Manufactured: 12/31/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other