MAUDE Adverse Event Report: THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC THERMO SCIENTIFIC AND CARDINAL HEALTH; BLOOD BANK REFRIGERATORS AND PLASMA FREEZERS

Model Number 1204, 1230

Device Problems Nonstandard Device (1420); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2020

Event Type  malfunction  

Manufacturer Narrative

There have been zero (0) reports of these devices tipping over nor any adverse events associated with the failure mode.This mdr is being submitted solely on the basis for potential injury if the issue were to occur.These units are 30.5 x 24.0 x 73.0 in.(77.5 x 61.9 x 185.4 cm) and 350 lb.Potential health consequences are a range: · none, if the unit were to tip when there aren't individuals around or a unit tips and the person is able to get out of the way and not be struck by the unit as it falls.· minimal - if a person is struck by part of the equipment on a limb, there could be pain and bruising plus or minus the need for medical care.· significant - if the unit tips and lands on top of a person, there is a risk of serious injury requiring medical care, there could be long term/permanent sequelae from the injury, or a person could be killed.The risk analysis found there is a risk of tipping between 1/1000 - 1/10,000 (or, risk of a tipping incident occurring being between one in 6 years and one in 60 years).Someone would have to be struck or pinned down by the unit in order for any injury to occur, which would likely be fewer than the total number of tipping incidences.The risk of serious adverse consequences (e.G., broken bones, head injury, crush injury, crush syndrome) is less than the risk of a tipping incident causing a minor injury.Note: i received an undetected.Xml error when attempting to submit this report through the esg on 09-jul-2020.Therefore, i am re-submitting it today (25-aug-2020).

Event Description

It was discovered internally that a portion of the 12 cubic foot blood bank refrigerators and 12 cubic foot plasma freezers manufactured during the period of may 2019 to june 2020 are missing a counterweight necessary to provide stability while the unit is being moved on its casters.During manufacturing in (b)(4) on 6/9/2020, a production associate familiar with the product was moving an assembly and noticed that the unit seemed lighter than it should.A quick investigation determined that some units have been assembled and distributed without the installation of the counterweights.Thermo fisher scientific is not aware of any reports of units tipping over or injuries associated with missing counterweights.

• Brand Name: THERMO SCIENTIFIC AND CARDINAL HEALTH
• Type of Device: BLOOD BANK REFRIGERATORS AND PLASMA FREEZERS
• Manufacturer (Section D): THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC; 275 aiken rd.; asheville, nc
• Manufacturer (Section G): THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC; 275 aiken rd; asheville, nc
• Manufacturer Contact: kelli tanzella ; 3175 staley rd; grand island, ny ; 7743122
• MDR Report Key: 10452245
• MDR Text Key: 205472643
• Report Number: 1036832-2020-00001
• Device Sequence Number: 1
• Product Code: KSE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510(K)EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1204, 1230
• Device Catalogue Number: TSX1204BA, TSX1230LA, CH1204BA
• Device Lot Number: N/A, UNITS ARE SERIALIZED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1036832-07102020-C
• Patient Sequence Number: 1