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	Defective Component (2292)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	08/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that bd alaris pump  module low sorbing set safety clamp failed causing hypotension and the need for medical intervention.The following information was provided by the initial reporter: complaint category: fail to function / defective.Safety clamp had failed that was previously infusing propofol via peripheral iv failed and pt.Accidently got a propofol bolus.1st customer response: ¿ are you able to provide the batch number? no¿that information is not available.¿ was there a delay of, or change in, the course of treatment due to the event? no.¿ was there damage/break on the clamp? no.¿ was there an alaris pump and pump module in use at the time of the event? yes.If so, what pump module model was in use (8100, 8110, 8120)? 8100.Add info from distributor: 1.Was there any injury /adverse effect to the patient that required additional medical care due to the reported issue below? yes, patient¿s blood pressure decreased below goal.If yes: what was the injury / adverse effect? drop in blood pressure.What type of treatment was provided? increased flow rate of levophed infusion from 6 to 8 mcg/min.How is the patient doing now? stable.Was there any medication provided to the patient due to the reported issue below? yes.If yes: what is the name of the medication given to the patient? levophed (norepinephrine).Was the medication over the counter or prescribed by a physician? prescribed.Was the medication taken orally or by iv or applied topically? iv.2.What is the lot number of the affected product? the packaging for the tubing is not available but the tubing has a tag on it with 630-01575 rev 00.3.What type of procedure was being performed? discontinuing a propofol infusion and removing the line from the pump.
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.6.Investigation summary: a complaint of clamp failing was received from the customer.No product or photo was returned by the customer.The customer complaint of clamp issues/ damage related to the clamp could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 2260-0500 because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.H3 other text : see h.10.

• 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: 17795561
• Report Number: 9616066-2023-01918
• Device Sequence Number: 17829769
• Product Code: FPA
• UDI-Device Identifier: 37613203012608
• UDI-Public: (01)37613203012608
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 09/04/2023

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 Catalogue Number: 2260-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 09/21/2023
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown