MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. HOME HEMO COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2962-3

Device Problem Detachment Of Device Component (1104)

Patient Problem Unspecified Infection (1930)

Event Date 02/06/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, and the lot number was not provided.Therefore, the failure mode cannot be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.The reported event occurred in (b)(6); therefore the product was distributed by (b)(4).(b)(4) performed a manufacturing review of the products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius bloodline products from the reported catalog number (03-2962-3) shipped to this account within the selected time frame.A records review was performed on all lots identified.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 lots passed all release criteria.A review of the batch production records did not reveal a probable cause for the customer complaint.There were no non-conformances identified that relate to the reported event, and all lots met release criteria.

Event Description

A home hemodialysis (hhd) patient reported that the cap from the heparin line of the fresenius home hemo comibiset was very loose and fell off, which allegedly resulted in an infection.The type of infection is not known, and no information was provided detailing what, if any, medical intervention was required to treat the infection.Although requested, no further event details have been made available.The complaint device is not available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation, and the lot number was not provided.Therefore, the failure mode cannot be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.The reported event occurred in (b)(6); therefore the product was distributed by (b)(4).(b)(4) performed a manufacturing review of the products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius bloodline products from the reported catalog number (03-2962-3) shipped to this account within the selected time frame.A records review was performed on all lots identified.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 lots passed all release criteria.A review of the batch production records did not reveal a probable cause for the customer complaint.There were no non-conformances identified that relate to the reported event, and all lots met release criteria.Clinical investigation: a fresenius clinician concluded that although a temporal association may exist between the bloodlines¿ heparin cap either being off or very loose and the blood infection on the heart valve that was experienced by the patient, a possible causality cannot be established based on the lack of available information.Additional information related to the event and emergency room (er) visit are needed to determine potential causality.Further information including medical records have been solicited.

Event Description

Follow-up was received which revealed the patient had a blood infection on the heart valve.The nurse estimated that the patient had the infection for approximately three (3) weeks.The patient went to the emergency room (er) and received antibiotics to treat the infection.Upon inquiring about the patient¿s current status, it was reported that the patient still has the infection.The nurse was not able to confirm if the patient used the bloodline after observing the issue.Furthermore, the nurse stated that the heparin cap detachment was believed to ¿have occurred 1-2 times,¿ but could not confirm.The nurse instructed the patient to discard the bloodline if the issue recurs and to not use a potentially damaged product.

• Brand Name: HOME HEMO COMBI SET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6385897
• MDR Text Key: 69323188
• Report Number: 8030665-2017-00098
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 03-2962-3
• Other Device ID Number: 00840861100330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other