MAUDE Adverse Event Report: TERUMO BCT HARVEST TERUMO; APC-20 PROCEDURE PACK

Catalog Number 51402

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Swelling (2091)

Event Date 06/30/2017

Event Type  Injury  

Manufacturer Narrative

Additional product code: fmf investigation: per the customer, the patient was given antibiotics prophetically prior to surgery.During the procedure, blood was collected and processed, then administered to the patient without issue.Investigation is in process.A follow-up report will be provided.

Event Description

The customer called to report that a patient underwent a dental implant surgery on (b)(6) 2017 and was treated with platelet rich plasma (prp) product.Approximately one week post procedure, the patient developed painful swelling, exudate, and redness in the jaw close to the implant.The patient re-visited the physician at the customer's site.Per physician's order,the patient was given oral antibiotics for several weeks and was released from physician care.The customer reports that the patient is improving and in healthy condition.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Based on the journal article complication rate in 200 consecutive sinus lift procedures: guidelines for prevention and treatment, the most frequent post operative complication for a sinus lift procedure was wound infections, which occurred in 7.1% of the patients in the study.Per terumo bct's internal documentation, when blood product becomes contaminated following collection, and separation using a terumo bct terminally sterilized device, it is highly unlikely the source of the bacteria was the disposable used to the collect and separate the blood product.Due to the nature of collection blood from humans contamination will occur at some frequency.Additionally, the sterility assurance system employed at terumo bct ensures that the device is not the source of contamination.Citation:moreno vazquez, j.C., gonzalez de rivera, a.S., gil, h.S., & mifsut, r.S.(2014).Complication rate in 200 consecutive sinus lift procedures: guidelines for prevention and treatment.Journal of oral and maxillofacial surgery, 72(5), 892-901.Doi:10.1016/j.Joms.2013.11.023 investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information and corrected the product code.Investigation: there have been no other reports of patient infection complaints against this production lot number.Two years of data was reviewed and no other occurrences of patient infection with harvest disposables were identified.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the customer stated that they treated a total of 6 patients with prp collected from the reported production lot number, however, of the 6 patients treated, a total of 3 patients had infections post procedure.There have been no other reports of patient infection complaints against this production lot number.Three years of data was reviewed and no other occurrences of patient infection with harvest disposables were identified.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The sterilization process ran as expected and there were no non-conformances or observations.Based on the sterility assurance system employed at terumo bct, the disposable device is not a likely source of the contamination.Potential sources for the contamination are improper aseptic technique and the aspirate coming in contact with non-sterile fluids.The disposable set was not available for return.However, the customer returned the remaining procedure pack back for investigation.The customer returned 2 unused platelet rich plasma procedure pack and an unused applicator.The expiration dates on the set was (b)(6) 2017 and none of the associated components had expiry dates prior to the set expiration.The applicator that was returned expired on 2017-06-01.This is prior to the procedure date, but the customer did not indicate that this was the lot of applicators that was used to perform this procedure.No other observations or abnormalities were noted in the returned product.Root cause: a definitive root cause could not be determined.Possible causes include but are not limited to:- improper aseptic technique and/or skin preparation- aspirate contacted non-sterile fluids.

• Brand Name: HARVEST TERUMO
• Type of Device: APC-20 PROCEDURE PACK
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6788690
• MDR Text Key: 82503888
• Report Number: 1722028-2017-00320
• Device Sequence Number: 0
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/11/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Catalogue Number: 51402
• Device Lot Number: 09Z9940
• Other Device ID Number: 05020583514027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 98