MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. BULK PACK TRANSDUCER PROTECTOR; PROTECTOR, TRANSDUCER, DIALYSIS

Catalog Number	04-9500-2
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental medwatch report will be submitted upon completion of the investigation.
Event or Problem Description
A clinic manager from a hemodialysis (hd) patient's facility reported during hd treatment the transducer protector came loose from the dialysis lines and experienced blood loss during the event.Additional follow-up revealed the transducer protector came loose one hour after treatment was initiated.The estimated blood loss was 500mls.No patient injury was reported.The patient was given a saline bolus and refused to go to the emergency room.When the patient was stable she went to the hospital and had a hemoglobin (hgb) drawn and it was within normal limits.The patient was monitored and her vital signs remained stable.No defect or damage was observed to the transducer protector or its packaging.The patient did not complete hemodialysis treatment.The sample was discarded.
Additional Manufacturer Narrative
The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.The entire lot has been sold and distributed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.
Event or Problem Description
A clinic manager from a hemodialysis (hd) patient's facility reported during hd treatment the transducer protector came loose from the dialysis lines and experienced blood loss during the event.Additional follow-up revealed the transducer protector came loose one hour after treatment was initiated.The estimated blood loss was 500mls.No patient injury was reported.The patient was given a saline bolus and refused to go to the emergency room.When the patient was stable she went to the hospital and had a hemoglobin (hgb) drawn and it was within normal limits.The patient was monitored and her vital signs remained stable.No defect or damage was observed to the transducer protector or its packaging.The patient did not complete hemodialysis treatment.The sample was discarded.

• Brand Name: BULK PACK TRANSDUCER PROTECTOR
• Common Device Name: PROTECTOR, TRANSDUCER, DIALYSIS
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 7008585
• Report Number: 8030665-2017-00946
• Device Sequence Number: 11080884
• Product Code: FIB
• UDI-Device Identifier: 00840861100545
• UDI-Public: 00840861100545
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K003445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 04-9500-2
• Device Lot Number: 15SR01122
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 11/23/2017
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 41