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

Catalog Number 03-2722-9

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

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

Event Date 07/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the reported complaint was not confirmed as the complaint device was not available for manufacturer evaluation.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.The lot passed all release criteria.Review of the batch production record (bpr) did not reveal a probable cause for the customer complaint.

Event Description

A user facility reported that an external blood leak occurred while a patient was undergoing a hemodialysis (hd) treatment.The blood leak was observed where the line connected to the injection site.Reportedly, the leak allowed air to enter the lines which led to a machine alarm being generated.The patient's estimated blood loss (ebl) was noted as being approximately 300ml, or the amount of blood within the extracorporeal circuit.No patient adverse effects were experienced and no medical intervention was required.The patient was setup with new supplies on the same machine, and then the treatment was continued.The treatment was successfully completed with no further issues.Follow-up information was provided which noted that damage was present to the bloodline.The complaint device is available to be returned to the manufacturer for evaluation.Although requested, the device has not been received.

Manufacturer Narrative

The complaint device was returned to the manufacturer for physical evaluation.Two samples were returned to the manufacturer inside of a bag identified with code number (b)(4), lot number 16br01431.The samples consisted of portions of the tubes assembled to the arterial injection site.A visual inspection of the two returned devices revealed a crack in one of the arterial injection sites and no crack or defect observed in the second device.The two devices were subjected to a functional leak test, which confirmed the alleged failure that the device with the crack consequently led to the set leaking.The second device without the crack passed the functional leak test and no leaks were observed.The crack in one of the returned devices is attributed to a defective supplier part or to the application of excessive force on the injection site.A records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.The lot passed all release criteria.The reported complaint of a fluid leak in the line was confirmed.A visual examination of the two returned devices identified a crack in one of the devices.Although no defect was identified with the second bloodline product returned, this complaint has been deemed confirmed, based on the investigation findings which revealed the presence of a leak at the location of the observed crack.

• Brand Name: CUSTOM COMBI SET
• 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: 5903735
• MDR Text Key: 54046089
• Report Number: 8030665-2016-00440
• 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,Followup
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 16BR01431
• Other Device ID Number: 00840861100293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2016
• 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