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 Problems Fluid/Blood Leak (1250); Material Separation (1562)

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

Event Date 04/21/2017

Event Type  malfunction  

Manufacturer Narrative

The reported complaint is 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 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 a blood leak occurred approximately 15 minutes after initiation of the patient's hemodialysis (hd) treatment.The blood leak was noted as being a bloodline tubing leak.The machine did not alarm as it is not intended to do so.Blood was visually observed leaking externally from the transducer line which had separated from the transducer.Other than the line separation, no damage to the bloodline or its packaging was observed.The patient¿s estimated blood loss (ebl) was noted as being approximately 50 cubic centimeters (cc).No patient adverse effects were experienced and no medical intervention was required as a result of this event.The patient completed treatment with a new set-up on a different machine.The complaint device was not available to be returned to the manufacturer for evaluation as it was discarded by the user facility.

• 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: 6572469
• MDR Text Key: 75385174
• Report Number: 8030665-2017-00248
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 03-2962-3
• Device Lot Number: 16JR01121
• Other Device ID Number: 00840861100330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2016
• 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
• Treatment: FRESENIUS 2008K HEMODIALYSIS MACHINE; FRESENIUS OPTIFLUX F180NRE DIALYZER FINISHED ASSY.
• Patient Age: 37 YR
• Patient Weight: 99