MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 FAST FLOW FLUID WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Model Number H-1200

Device Problems Connection Problem (2900); Failure of Device to Self-Test (2937)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

It was reported that the device failed a safety test and the dsta-40 component was difficult to connect to the device.The issue occurred during preventive maintenance, no patient involvement.

Manufacturer Narrative

B3: date of event is unknown, no information has been provided to date.A product sample was received and is awaiting evaluation, investigation including root cause analysis is in progress.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

One device was received.Per visual inspection, the device has a non-oem plug on the line cord.The display label is damaged.The ground stud for testing has been replaced with a bolt.The return tube has been removed and placed incorrectly over the membrane switch.There is evidence of fluid ingression on the printed circuit board (pcb).Heater #2 has a rip in the heater insulation tape.The compressor shows signs of fluid ingression.The bottom socket thermistor is not seated correctly in the socket.The top socket thermistor has been seated incorrectly, and the fan guard/filter is clogged with dust.Per functional testing, the device had a bolt and other hardware in place of the ground stud on the back panel, these were replaced with the correct parts for electrical testing.The line cord also had a non-oem plug on it.The device passed electrical testing; no problem found.The dsta-40 was not designated as a complaint and was serviced separately by another technician, so it was not investigated jointly with the tower.The complaint could not be confirmed or replicated, but the tower has multiple other components needing replacement.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.No action taken due to the condition of the device.It was deemed beyond economical repair and was scrapped.

• Brand Name: LEVEL 1 FAST FLOW FLUID WARMER
• Type of Device: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18699249
• MDR Text Key: 335278050
• Report Number: 3012307300-2024-00768
• Device Sequence Number: 1
• Product Code: BSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK020043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: H-1200
• Device Catalogue Number: 8002950
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/06/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1