MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FMC BLOODLINES; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Device Problem Decoupling (1145)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported complaint is not confirmed as the complaint device was not available for manufacturer evaluation, and the lot number of the suspect device was not provided.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A lot history review was performed of the products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date.No information was found and no lots were identified during this review, which sought to identify the lot numbers for all bloodline tubing sets shipped to this account within the selected time frame.As the lot number was not identified by the user facility and since no lot information was identified during the ship history, a manufacturing review was not able to be performed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.Follow-up information, provided by the complainant, confirmed that the incident was caused by the end user.The transducer line disconnected while the staff made adjustments to the machine.Reportedly, the connection was not properly tightened and was left loose during set-up.Moreover, no additional complaints have been received from this user facility to suggest an on-going product issue.Therefore, this complaint has been deemed not confirmed.

Event Description

The nurse manager at the user facility reported that the transducer line disconnected while a patient underwent their hemodialysis (hd) treatment.Follow-up was provided which revealed that the connection was not properly tightened and was left loose during set-up.Therefore, the transducer line separated after being accidently bumped while the staff made adjustments to the hd machine.The patient's estimated blood loss (ebl) was noted as being approximately 100cc.No patient adverse effects were experienced and no medical intervention was required as a result of this event.The complaint device is not available to be returned to the manufacturer for evaluation as it was discarded by the user facility.

• Brand Name: FMC BLOODLINES
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer Contact: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5857138
• MDR Text Key: 52521672
• Report Number: 8030665-2016-00404
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/09/2016

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2016
• Initial Date FDA Received: 08/09/2016
• 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