MAUDE Adverse Event Report: CONCORD MANUFACTURING CRIT-LINE CLIP (CLIC) - USB; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Catalog Number	CL10041001
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility biomedical technician (bmt) reported to technical support that a clic crit-line clip won't calibrate and caused the circuit board to burn out.Upon follow-up, the bmt stated the there were no diagnostic messages or audible alarms.The bmt stated there was no patient involvement, patient harm, or adverse event reported.The bmt stated the circuit board appeared burnt and confirmed there was no smoke, fire or burning smell as associated with the reported event.The bmt replaced the circuit board to resolve the reported issue.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and does not have a previous history of failing an electrical leakage test.The replaced component was returned for investigation.
Event or Problem Description
A user facility biomedical technician (bmt) reported to technical support that a clic crit-line clip won't calibrate and caused the circuit board to burn out.Upon follow-up, the bmt stated the there were no diagnostic messages or audible alarms.The bmt stated there was no patient involvement, patient harm, or adverse event reported.The bmt stated the circuit board appeared burnt and confirmed there was no smoke, fire or burning smell as associated with the reported event.The bmt replaced the circuit board to resolve the reported issue.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and does not have a previous history of failing an electrical leakage test.The replaced component was returned for investigation.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: exterior inspection revealed corrosion on the interior and exterior of the usb connector.Thermal damage was not observed on the usb connector.The clic device had no other damage.Power-on test failed (clm iv).The returned clic device failed to power on when attached to a clm iv.The wires of the usb cable passed a continuity test.Internal inspection found no discrepancies, none of the clic¿s circuit boards had thermal damage.Due to the power failure, the clic device could not be tested for the reported calibration problem.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, the reported issue was confirmed and the cause was determined to be traced to component failure.

• Brand Name: CRIT-LINE CLIP (CLIC) - USB
• Common Device Name: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 17551670
• Report Number: 0002937457-2023-01215
• Device Sequence Number: 6797318
• Product Code: KOC
• UDI-Device Identifier: 00840861101139
• UDI-Public: 00840861101139
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K121599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: CL10041001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown