MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH CLOTTING FACTOR V DEFICIENT PLASMA

Model Number SEE SECTION H10

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 02/13/2020

Event Type  malfunction  

Manufacturer Narrative

The affected product (clotting factor v deficient plasma, catalog number: 10446269, lot number: 504974) is not distributed in the united states.This mdr is being filed for similar product.Clotting factor v deficient plasma is distributed in the united states under catalog number (10446271).Siemens is investigating the issue.

Event Description

Siemens personnel observed that several clotting factor v deficient plasma vials (lot number: 504974) had a higher factor v concentration than would be expected.Out of 30 vials, 5 of the vials had a factor v concentration between 72.4% and 76%, instead of <5% which is expected.There are no reports of patient intervention or adverse health consequences due to this event.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2020-00009 on 13-mar-2020.Additional information (19-mar-2020): siemens has determined that there is no risk to health as a result of the clotting factor v deficient plasma vials (catalog number: 10446269 , lot number: 504974) having a higher factor v concentration than would be expected.The incorrect vials will lead to quality control (qc) results recovering out of range.Additional information (23-mar-2020): siemens' investigation has determined that the cause of a higher factor v concentration than would be expected with the clotting factor v deficient plasma lot number 504974 was due to human error during the manufacturing process.One box containing 288 vials of pt multi calibrator level 3 (lot number: 555393) was loaded into the freeze dryer where vials of factor v deficient plasma (lot number: 504974) were located and were included in the kitting of clotting factor v deficient plasma kits for lot number 504974.There is no potential for an erroneous patient result.The clotting factor v deficient plasma, which is distributed in the united states under catalog number 10446271, is not affected by this issue and is performing according to specifications.No further evaluation of this device is required.

• Brand Name: CLOTTING FACTOR V DEFICIENT PLASMA
• Type of Device: CLOTTING FACTOR V DEFICIENT PLASMA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 9830450
• MDR Text Key: 191037201
• Report Number: 9610806-2020-00009
• Device Sequence Number: 1
• Product Code: GJT
• Combination Product (y/n): N
• PMA/PMN Number: K924394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SEE SECTION H10
• Device Catalogue Number: SEE SECTION H10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1