MAUDE Adverse Event Report: ZHEJIANG HUAWEI SCIENTIFIC INSTRUMENT CO. LTD. LW SCIENTIFIC ZIP-IQ PCV CENTRIFUGE; HEMATOCRIT CENTRIFUGE

Model Number HW24H

Device Problems Fracture (1260); Material Fragmentation (1261); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)

Patient Problems Abrasion (1689); Laceration(s) (1946)

Event Date 10/29/2020

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2020, we received a notice from our u.S.Distributor that the outer rim of an hw24h centrifuge rotor had broken in a veterinary office.Two small pieces of the plastic rotor were ejected from the centrifuge and struck two technicians, who sustained minor injuries.They were not treated for the injuries, as they were minor cuts and scrapes.The distributor replaced the centrifuge for the vet office and requested the centrifuge be returned to them.It may be noted that the user reported hearing unusual noises in the centrifuge in the two previous runs and decided to run the centrifuge a third time, which is when the malfunction occurred.The distributor evaluated the returned centrifuge, and their findings indicate that the problem arose due to the user failing to properly tighten the rotor lid onto the motor shaft.During the spin, the nut holding the rotor lid loosened, causing the rotor lid to spin freely.The loose rotor lid caused the rotor to spin in an unbalanced manner.The rotor then contacted the lid and bowl, causing breakage in the outer edge of the rotor.

Event Description

For a centrifuge being used in a vet office, a small piece of the rotor rim broke apart during use.Pieces of plastic struck two technicians both of whom sustained minor injuries.They did not seek medical attention.

• Brand Name: LW SCIENTIFIC ZIP-IQ PCV CENTRIFUGE
• Type of Device: HEMATOCRIT CENTRIFUGE
• Manufacturer (Section D): ZHEJIANG HUAWEI SCIENTIFIC INSTRUMENT CO. LTD.; 237 zhang yang road; linhai,; zhejiang, 31700 0; CH 317000
• Manufacturer (Section G): ZHEJIANG HUAWEI SCIENTIFIC INSTRUMENT CO. LTD.; 237 zhang yang road; linhai; zhejiang, 31700 0; CH 317000
• Manufacturer Contact: wenhua liang ; 237 zhang yang road; linhai; zhejiang, 31700-0 ; CH 317000
• MDR Report Key: 10942744
• MDR Text Key: 220172618
• Report Number: 3011816315-2020-00001
• Device Sequence Number: 1
• Product Code: GKG
• UDI-Device Identifier: 00664816002629
• UDI-Public: 00664816002629
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HW24H
• Device Catalogue Number: HW24H
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2018
• 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