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

Catalog Number	11426964
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that bd alaris pump module low sorbing infusion set separated and leaked.The following information was received by the initial reporter with the verbatim: good morning.On (b)(6) 2023, we had a safety event reported for (bd alaris pump infusion set low sorb tubing).Let¿s identify this as bd 248, as a reference number.The tubing has been discarded.Based on the information provided below, could you start a product quality report? event details: ¿low sorb iv tubing.When i was circle priming chemo at med room at xxx pod.The iv tubing popped at filling chamber, spilled out chemo about 10cc.Used chemo spill kit to clean that area.Around 5 cc spill happened on my left hand, which was double gloved.Spilling chamber couldn't hold pressure during circle prime.I just pushed two times.When i was doing second time it popped out.¿.
Additional Manufacturer Narrative
Investigation summary: no product or photo was returned by the customer.The customer complaint of separation other component - leak could not be verified due to the product not being returned for failure investigation.A device history record review for material# 11426964 and lot# 23075066 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.
Event or Problem Description
It was reported that bd alaris pump module low sorbing infusion set separated and leaked.The following information was received by the initial reporter with the verbatim: good morning.On 9/17/2023, we had a safety event reported for (bd alaris pump infusion set low sorb tubing).Let¿s identify this as bd 248, as a reference number.The tubing has been discarded.Based on the information provided below, could you start a product quality report? event details: ¿low sorb iv tubing.When i was circle priming chemo at med room at xxx pod.The iv tubing popped at filling chamber, spilled out chemo about 10cc.Used chemo spill kit to clean that area.Around 5 cc spill happened on my left hand, which was double gloved.Spilling chamber couldn't hold pressure during circle prime.I just pushed two times.When i was doing second time it popped out.¿.

• Brand Name: BD ALARIS PUMP MODULE LOW SORBING INFUSION 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: 17865876
• Report Number: 9616066-2023-02003
• Device Sequence Number: 12522983
• Product Code: FPA
• UDI-Device Identifier: 50885403232365
• UDI-Public: (01)50885403232365
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023

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: Other
• Device Catalogue Number: 11426964
• Device Lot Number: 1023075066
• 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: Not provided
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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