MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. UNSPECIFIED BD PRI TUBING SET; PRIMARY TUBING SET

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Free or Unrestricted Flow (2945)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that 2 unspecified bd pri tubing sets experienced air bubbles/air in line and device damage/deformation.The following information was provided by the initial reporter: scenario 1 - nurse noticed collapsed iv bag and collapsed drip chamber and air line line all the way to the pump, but not below.No alarm.No patient harm.Scenario 2 - same nurse, same patient, new bag, new tubing.Same things above happened, however, in this scenario there was approximately 1/2 inch to 1 inch of air in the line below the device.No alarm.No patient harm.Nurse concerned and contacted biomed and risk mgmt.Risk mgmt has sequestered the one pcu, one lvp and both tubing sets that were used.No patient harm.Nurse concerned.

Manufacturer Narrative

The following fields were updated due to additional information: d.10 device available for eval: yes.D.10 returned to manufacturer on: 09/18/2020.Investigation conclusion: one sample was returned by the customer.It was reported that there was air in the line.The set was primed and infused at 100 ml / hr.The set was examined for defects in the tubing.No defects were observed.The customer complaint could not be verified because the failure could not be replicated.A device history record review could not be performed because a model or lot number was not provided by the customer.A root cause could not be determined because the failure could not be replicated.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text: see h10.

Event Description

It was reported that 2 unspecified bd pri tubing sets experienced air bubbles/air in line and device damage/deformation.The following information was provided by the initial reporter: scenario 1 - nurse noticed collapsed iv bag and collapsed drip chamber and air line line all the way to the pump, but not below.No alarm.No patient harm.Scenario 2 - same nurse, same patient, new bag, new tubing.Same things above happened, however, in this scenario there was approximately 1/2 inch to 1 inch of air in the line below the device.No alarm.No patient harm.Nurse concerned and contacted biomed and risk mgmt.Risk mgmt has sequestered the one pcu, one lvp and both tubing sets that were used.No patient harm.Nurse concerned.

• Brand Name: UNSPECIFIED BD PRI TUBING SET
• Type of Device: PRIMARY TUBING SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.; blvd. insurgentes 20351; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10480555
• MDR Text Key: 224842237
• Report Number: 9616066-2020-02695
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015, (B)(6) 2020.; 8100,8015, (B)(6) 2020.
• Patient Outcome(s): Other