MAUDE Adverse Event Report: DATASCOPE FAIRFIELD ECC ACCESSORY PACK BEQ-T 52100; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number 709000118

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Difficult to Remove (1528); Torn Material (3024)

Patient Problem No Information (3190)

Event Date 09/22/2016

Event Type  malfunction  

Manufacturer Narrative

The customer indicated the device is unavailable, it will not be returning to the manufacturer and we're unable to complete an evaluation on the affected product.If the status regarding the product return changes or additional information is provided we will send a supplemental report with additional findings.(b)(4).

Event Description

The customer stated three issues occurred with the pack; there was a leaky cap on the transfusion bag, a dead end piece on the small reservoir is very loose and the sterile peel is difficult to take off and tears easily.

Manufacturer Narrative

The customer indicated the device is unavailable, it will not be returning to the manufacturer and we're unable to complete an evaluation on the affected product.If the status regarding the product return changes or additional information is provided we will send a supplemental report with additional findings.(b)(4).Supplement - contact office and date received by mfg was missing from the initial emdr (record id:1(b)(4)).

Event Description

The customer stated three issues occurred with the pack; there was a leaky cap on the transfusion bag, a dead end piece on the small reservoir is very loose and the sterile peel is difficult to take off and tears easily.

• Brand Name: ECC ACCESSORY PACK BEQ-T 52100
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 6041124
• MDR Text Key: 57875098
• Report Number: 2248146-2016-00083
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K08059223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 709000118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1