MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. CARELINE AIRLESS STANDARD PRE-PUMP BLOOD; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-4200-6

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility biomedical technician (biomed) reported a blood leak from the bloodline that occurred at the beginning of the patient¿s hemodialysis (hd) treatment.Per the biomed, the blood leak was coming from the bloodline itself, and not at a connection to another product.The patient's estimated blood loss (ebl) was approximately 250 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Device evaluation: the actual sample was returned to the manufacturer for physical evaluation.A simulated use test was performed on the sample for four hours.During the period tested no air bubbles inside the system was noticed, no leaks, no level variation of arterial and venous chamber, or any alarm.No leaks were observed in the pod from the diaphragm to the monitor line.The sample tested worked as intended without any abnormalities during the tested period.The diaphragm seal in the pod was tested for leaks and none were observed.In addition, the diaphragm was removed from the pod assembly on the venous and arterial lines and tested with acceptable results in both the pressure drop test and underwater leak test.An investigation of the device history records (dhr) was conducted by the manufacturer.There were no nonconformances or abnormalities identified during the manufacturing process which could be associated with the reported event.In addition, the dhr review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The complaint device performed as designed and an associated cause could not be determined and the alleged failure was not confirmed.

• Brand Name: CARELINE AIRLESS STANDARD PRE-PUMP BLOOD
• 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: 7409422
• MDR Text Key: 105247830
• Report Number: 8030665-2018-00517
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

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
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 03-4200-6
• Device Lot Number: 17JR01808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Initial Date Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 04/09/2018
• Supplement Dates Manufacturer Received: 05/11/2018
• Supplement Dates FDA Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2018
• 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: 49 YR
• Patient Weight: 71