MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. EXT MINIBORE QUAD-FSEE, 4IV CNNTRS.4CKVS; INTRAVASCULAR ADMINISTRATION SET

Model Number	MZ9283
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 1 ext minibore quad-fsee, 4iv cnntrs.4ckvs leaked during use.The following was reported by the initial reporter: "our resuscitation department reported 2 events with potentially serious consequences related to the 4-way connectors reference mz9283.Twice there was a leak in the amine pathway leading to patient failure.For the 2nd report on (b)(6) 2021, a leak was noted which persisted after the track was tightened.In both cases the batch number is not known but the devices have been kept.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: (b)(4).Investigation summary: one (b)(6) sample was received for investigation with residual fluid; no packaging was received with the sample, however analysis of the laser id printed on the maxzero components indicated the affected lot number to be 20055567.Additionally an unknown picc line was received connected to the (b)(6), which was also connected to an unknown extension set.A visual inspection of the (b)(6) sample did not identify signs of damage or manufacturing defects which could have contributed to the customer's experience.Functional testing was performed by flushing all the lines and by applying pressure testing to each line whilst connected to the picc line; no leakage was identified during testing at any point of the sample or the connection.Furthermore, air pressure was then applied to the sample whilst submerged under water; again, no leakage was identified throughout testing.The details of this feedback were forwarded to the manufacturing site for investigation.It was not possible to confirm the root cause of the reported issue in this instance.Testing of the returned samples did not identify any product defects or quality deviations that could have contributed to the customer¿s experience.A review of the production records for lot 20055567 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.
Event or Problem Description
It was reported that 1 ext minibore quad-fsee, 4iv cnntrs.4ckvs leaked during use.The following was reported by the initial reporter: "our resuscitation department reported 2 events with potentially serious consequences related to the 4-way connectors reference (b)(4).Twice there was a leak in the amine pathway leading to patient failure.For the 2nd report on (b)(6) 2021, a leak was noted which persisted after the track was tightened.In both cases the batch number is not known but the devices have been kept.".

• Brand Name: EXT MINIBORE QUAD-FSEE, 4IV CNNTRS.4CKVS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• MDR Report Key: 11608845
• Report Number: 9616066-2021-50650
• Device Sequence Number: 4022348
• Product Code: FPA
• UDI-Device Identifier: 50885403230668
• UDI-Public: 50885403230668
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MZ9283
• Device Catalogue Number: MZ9283
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention