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

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

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

Event Date 04/04/2017

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon the completion of this activity.

Event Description

The biomedical technician at the user facility reported that the patient experienced blood loss while undergoing a routinely scheduled hemodialysis (hd) treatment.The patient¿s blood backed up to the external transducer protector on the level detector module of the 2008t hd machine which resulted in the incident.The patient's estimated blood loss (ebl) was noted as being approximately 100 cubic centimeters (cc).Follow-up was provided by the clinic manager who indicated that the machine generated a venous pressure alarm when the blood backed up to the external transducer protector.The clinic manager further revealed that the transducer was not properly connected and subsequently came loose.Blood splatter was also observed on the module's faceplate which occurred during the removal of the transducer protector.The patient was re-setup on the same machine, and then the hd therapy was continued and successfully completed.No patient adverse effects were experienced and no medical intervention was required as a result of this event.No damage was observed to the 2008t hd machine or any of the system components.No repairs were necessary and none were performed.The unit has been returned to service at the user facility without a recurrence of the event as reported.The bloodline product has not been returned to the manufacturer for physical examination.

Manufacturer Narrative

The device was not returned to the manufacturer 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.A manufacturing 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.This review included the lot numbers for all fresenius bloodlines 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 non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The product involved met all specifications for release.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.

• Brand Name: FMC BLOODLINE
• 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: 6546050
• MDR Text Key: 74488671
• Report Number: 8030665-2017-00221
• 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: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• 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
• Device Age: MO
• Date Manufacturer Received: 05/15/2017
• 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 Age: 47 YR
• Patient Weight: 144