MAUDE Adverse Event Report: DATASCOPE FAIRFIELD BEQ-TOP 49101 CHILDRENS LARGE ECC PACK; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number 701067069R01

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No decontamination or visual inspection of product was performed since product was not returned.A photograph was provided by the customer and it was evaluated.The photo indicated that a stopcock was disconnected from the pressure line, a pigtail was disconnected, and a pressure line was broken off.The reported event of loose and broken components was confirmed.The most likely cause could not be determined.A lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.(b)(4).

Event Description

It was reported by the customer that custom tubing pack packaging has been getting progressively worse.The customer found that there were numerous loose connections, undone connections, and broken stopcocks.Also the customer stated that the pigtail was totally broken, a stopcock off of its pigtail, and a pigtail not even on the line.While priming one pigtail was broken and needed to be replaced.The customer had been informed that on closed caps on the stopcock, once you loosen them to de-air the port, the caps do not lock back down always.Many just spring and don't fully tighten.There was no patient involvement and therefore no reported injury.The date of the event is unknown.

• Brand Name: BEQ-TOP 49101 CHILDRENS LARGE ECC PACK
• 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: 7652308
• MDR Text Key: 113020309
• Report Number: 2248146-2018-00410
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2019
• Device Catalogue Number: 701067069R01
• Device Lot Number: 3000059724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 06/05/2018
• Date Device Manufactured: 09/18/2017
• 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