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

Catalog Number	2260-0500
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris pump  module low sorbing set was leaking and found to have pinholes upon inspection.The following information was provided by the initial reporter: during evening rounds rn went to check on tubing and found it was leaking fentynal.Contact pulled the tubing and ran saline to find issue, little pin holes had developed.Contact said it has been an ongoing issue but that this was the first time her safety team had been made aware.
Additional Manufacturer Narrative
There were 2 lot numbers reported to be involved.The information for the additional lot number is as follows: d4.Medical device lot #: 23055158.D4.Medical device expiration date: 05/15/2026.H4.Device manufacture date: 05/05/2023.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd alaris pump  module low sorbing set was leaking and found to have pinholes upon inspection.The following information was provided by the initial reporter: during evening rounds rn went to check on tubing and found it was leaking fentynal.Contact pulled the tubing and ran saline to find issue, little pin holes had developed.Contact said it has been an ongoing issue but that this was the first time her safety team had been made aware.
Additional Manufacturer Narrative
H6: investigation summary the customer provided a video for quality investigation.The customer complaint of component damage was verified by visual inspection.The video provided by the customer shows that the silicone tubing of the pumping segment would leak when stretched.The leakage was from the bottom of the silicone tubing at the junction with the lower pumping segment fitting.A device history record review for model 2260-0500 lot number 23055158 was performed.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 due to a physical sample not being provided.Based on the information provided by the customer, the leakage was not noticed during priming and therefore the probable root cause for the damage to the silicone tubing of the pumping segment is a misloading of the pumping segment.If the pumping segment is not loaded correctly, pinching and tearing of the pumping segment can cause leaks similar to the leakage seen in the customer's video.H3 other text : see h10.

• Brand Name: BD ALARIS PUMP MODULE LOW SORBING SET
• 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17647291
• Report Number: 9616066-2023-01819
• Device Sequence Number: 7301880
• Product Code: FPA
• UDI-Device Identifier: 37613203012608
• UDI-Public: (01)37613203012608
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/18/2026
• Device Catalogue Number: 2260-0500
• Device Lot Number: 23055404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown