MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. ALARIS SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2420-0007

Device Problems Complete Blockage (1094); Restricted Flow rate (1248)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).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 the unspecified bd primary pump set experienced flow issues, and was clogged.The following information was provided by the initial reporter: iv tubing had levophed running previously.I restored the pump to restart levo and it appeared to be running fine.I had to keep titrating up on the levo up to 0.1 with no improvement in the bp.I disconnected the line from the patient and pulled it from the channel to try to flush it through and the tubing had been completely cinched together within the channel.No levophed had been infused to the patient and the channel never alarmed.

Manufacturer Narrative

The following information has been updated/corrected: b.5.Describe event or problem: it was reported that the alaris set experienced flow issues, and was clogged.The following information was provided by the initial reporter: iv tubing had levophed running previously.I restored the pump to restart levo and it appeared to be running fine.I had to keep titrating up on the levo up to 0.1 with no improvement in the bp.I disconnected the line from the patient and pulled it from the channel to try to flush it through and the tubing had been completely cinched together within the channel.No levophed had been infused to the patient and the channel never alarmed.D.1.Medical device brand name: alaris set.D.1.Common device name: intravascular administration set.D.2.Medical device manufacturer: sistemas medicos alaris, s.A.De c.V.D.2.Medical device type: fpa d.4.Medical device catalog #: 2420-0007.D.4.Medical device lot #: unknown, (an invalid lot # of 21058843 was provided by the initial reporter).D.10.Device returned to manufacturer?: yes d.10.Date returned to manufacturer: 2020-08-31 d.4.Unique identifier (udi) #: (b)(4).G.1.Manufacturing location: sistemas medicos alaris, s.A.De c.V.G.5.Pma/510(k)#: k944320 h.3.Device returned to manufacturer?: yes.

Event Description

It was reported that the alaris set experienced flow issues, and was clogged.The following information was provided by the initial reporter: iv tubing had levophed running previously.I restored the pump to restart levo and it appeared to be running fine.I had to keep titrating up on the levo up to 0.1 with no improvement in the bp.I disconnected the line from the patient and pulled it from the channel to try to flush it through and the tubing had been completely cinched together within the channel.No levophed had been infused to the patient and the channel never alarmed.

Event Description

It was reported that the alaris set experienced flow issues, and was clogged.The following information was provided by the initial reporter: iv tubing had levophed running previously.I restored the pump to restart levo and it appeared to be running fine.I had to keep titrating up on the levo up to 0.1 with no improvement in the bp.I disconnected the line from the patient and pulled it from the channel to try to flush it through and the tubing had been completely cinched together within the channel.No levophed had been infused to the patient and the channel never alarmed.

Manufacturer Narrative

H.6.Investigation: one sample was returned for investigation.The set was examined for defects and abnormalities.Tubing was pinched in the middle of the pumping segment.A quality notification was sent to the supplier.From the supplier investigation no possible cause was found and the issue was unable to be replicated.Additionally, to evaluate the possibility of the pinch in the tube, taunton tried to replicate, by taking a hot tube from the production extruder right after processing and folded the tube and then placed it under a 5 lbs.Weight for a period of 7 days (1 week).The part was removed from being under compression after 1 week.The tubing retained its original shape almost immediately.Dhr was performed for the two possible lots: a device history record review for model 2420-0007 lot number 21055989 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0007 lot number 21055990 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h.10.

• Brand Name: ALARIS SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana NJ 22244
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana NJ 22244
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12489676
• MDR Text Key: 271977882
• Report Number: 2243072-2021-02343
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2420-0007
• Device Lot Number: 21058843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1