MAUDE Adverse Event Report: FENWAL INTERNATIONAL INC. PLASMACELL-C DISPOSABLE SET

Catalog Number 6R2280

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Patient Problem/Medical Problem (2688); No Information (3190)

Event Date 06/26/2018

Event Type  Injury  

Event Description

The donor had acute tubular nephropathy due to the elimination of hemolytic material.

Event Description

After a plasma collection performed on an aurora separator in italy, the donor had acute tubular nephropathy due to the elimination of hemolytic material.Medical intervention required immediate hydration therapy and the administration of cortisones.The patient entered a follow-up monitoring program and had a medical check-up every two weeks for two months.Further clarification of the incident revealed the donor experienced discolored urine due to reinfusion of hemolyzed blood.The immediate hydration therapy and the administration of cortisones is standard practice in italy for the reported condition.No additional information could be provided about the donor's health history.The donor completed their follow-up monitoring and did not require additional medical intervention.Currently, the donor is in good health.A fresenius kabi product specialist in italy reviewed the procedure report from the device that the donation was performed on, and verified the sensor detected pink plasma and alarmed as designed.A sample evaluation was performed.The evaluation consisted of visual inspection of the sample, autopsy of the tubing, microscopic examination, leak test of the membrane and a dental cast of the lower rotor cavity.Properly sealed plasma lines were noted.There were no scrape marks found on the rotor or inside the case.The leak membrane test passed.There were no defects with the seal ring, eyelet or pivot identified.The dental cast of the lower rotor cavity did not reveal deformation or defects.The evaluated kit had red discoloration in the plasma line.No manufacturing defects were discovered on the evaluated kit.A batch review was performed and the reported kit lot passed all sampling acceptance criteria for all testing performed including in-process, functional and product testing.Therefore, no root cause could be determined through the evaluation.

Manufacturer Narrative

Corrected data to initial report #3000240707-2018-00097: the mfr report number used the wrong manufacturer fei registration number.The correct fei registration number is 3002806457.The report number remains the same for traceability.The catalog # provided on the initial report was incorrect.The correct catalog # is 6r2280.Answered incorrectly on the initial report.The correct answer is no.Section f should have been left blank on the initial report as we are the manufacturer not the user facility or importer.Manufacturer narrative: after a plasma collection performed on an aurora separator in italy, the donor had acute tubular nephropathy due to the elimination of hemolytic material.Medical intervention required immediate hydration therapy and the administration of cortisones.The patient entered a follow-up monitoring program and had a medical check-up every two weeks for two months.Further clarification of the incident revealed the donor experienced discolored urine due to reinfusion of hemolyzed blood.The immediate hydration therapy and the administration of cortisones is standard practice in italy for the reported condition.No additional information could be provided about the donor's health history.The donor completed their follow-up monitoring and did not require additional medical intervention.Currently, the donor is in good health.A fresenius kabi product specialist in italy reviewed the procedure report from the device that the donation was performed on, and verified the sensor detected pink plasma and alarmed as designed.A sample evaluation was performed.The evaluation consisted of visual inspection of the sample, autopsy of the tubing, microscopic examination, leak test of the membrane and a dental cast of the lower rotor cavity.Properly sealed plasma lines were noted.There were no scrape marks found on the rotor or inside the case.The leak membrane test passed.There were no defects with the seal ring, eyelet or pivot identified.The dental cast of the lower rotor cavity did not reveal deformation or defects.The evaluated kit had red discoloration in the plasma line.No manufacturing defects were discovered on the evaluated kit.A batch review was performed and the reported kit lot passed all sampling acceptance criteria for all testing performed including in-process, functional and product testing.Therefore, no root cause could be determined through the evaluation.- attachment: [3000240707-2018-00097 response.Pdf].

• Brand Name: PLASMACELL-C DISPOSABLE SET
• Type of Device: PLASMACELL-C DISPOSABLE SET
• Manufacturer (Section D): FENWAL INTERNATIONAL INC.; carretera sánchez km 18.5; haina, san cristóbal, ; DR
• MDR Report Key: 7774164
• MDR Text Key: 116805894
• Report Number: 3000240707-2018-00097
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK110072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 6R2280
• Device Lot Number: FA17L18397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/13/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2018
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 08/10/2018
• Supplement Dates Manufacturer Received: 07/13/2018
• Supplement Dates FDA Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention